Browse
···
Log in / Register

CAPA Manager

$140,000-155,000/year

OrganOx

Madison, NJ, USA

Favourites
Share

Description

ABOUT ORGANOX: OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. We are a commercial stage organ technology company, spun out of the University of Oxford in 2008, committed to improving transplantation outcomes throughout the world. The company’s first product, the OrganOx metra® normothermic machine perfusion (NMP) system for liver transplantation, has been used to support more than 5,000 liver transplant operations globally. Position Summary We are seeking a passionate and detail-oriented CAPA Manager to lead the administration and reporting of our Corrective and Preventive Action (CAPA) system. This role is pivotal in ensuring that quality issues are addressed effectively and transparently, while fostering a culture of continuous improvement and compliance. The CAPA Manager will not own the CAPA actions themselves but will be responsible for overseeing the CAPA process runs in a manner that is compliant with ISO 13485 and associated regulations, ensuring timely and effective execution by CAPA owners, and reporting progress and effectiveness to senior management. Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally exhaustive. This is a primarily an on-site position with some hybrid working at OrganOx’s Giralda Farms US site to ensure the administration and reporting of our Corrective and Preventive Action (CAPA) system is lead effectively. Major Responsibilities Under direction from the Director, Quality Assurance, the CAPA Manager will be responsible for: ·       Administer the end-to-end CAPA process in compliance with regulatory requirements (e.g., ISO 13485, FDA 21 CFR 820). ·       Lead, coach and develop a direct report to build technical capability, problem-solving skills and ownership of CAPA administration function. ·       Monitor CAPA progress, ensuring timely closure and effectiveness verification. ·       Drive a culture of accountability for CAPA owners, ensuring actions are completed on time with scalable and sustainable corrective actions. ·       Prepare and present CAPA metrics, trends, and insights to senior leadership. Produce regular data driven reports that identify CAPA trends and feed into process, product or system changes. ·       Facilitate stone cross-functional collaboration to ensure issues are fully understood solutions are well-integrated and learnings are shared across the organization. ·       Maintain CAPA documentation and ensure audit readiness. ·       Leverage Continuous Improvement (CI) tools and methodologies to optimise the CAPA process for efficiency, effectiveness and prevention of recurrence. ·       Drive continuous improvement initiatives based on CAPA learnings. ·       Champion a team-focused, respectful approach to problem-solving and accountability. ·       Adhere to the letter and spirit of OrganOx’s Values, Code of Conduct and all other company policies. Requirements Skills & Experience ·       Effective interpersonal skills to achieve outcomes through influence. ·       Clear communicator both verbally and in writing. ·       Ability to process complex data to enable actionable insights. ·       Demonstrated ability to lead and develop team members, fostering growth and performance.   Qualifications ·       Minimum of bachelor’s degree in a Life Science, Engineering or Technical subject. ·       At least 2 years’ experience in leading CAPA Management with a proven track record of driving CAPA’s to a timely closure and ensuring sustained effectiveness. ·       3-4 years of related work experience in Medical Devices, Pharmaceuticals or other regulated industry. ·       Experience in eQMS systems such as MasterControl, TrackWise, Windchill or others. ·       Ability to travel internationally up to 10%. ·       At least 1 or more years’ of line management experience, managing direct reports. #LI-Hybrid A job description does not imply that the duties stated are the only ones to be performed by the job holder. Job holder will be required to follow any other job-related instruction as reasonably requested by their line manager or their designate. Benefits The Pay Range for this position is $140,000 - $155,000 annually, with a 20% target annual bonus and benefits. We offer competitive compensation and comprehensive benefits available from day one, including health, dental, vision, disability coverage, and flexible spending accounts. Additionally, we offer a 401(k)-retirement plan with company matching after 90 days, paid time off, holidays, and additional leave benefits, as well as employee discounts and access to our onsite wellness facility. OrganOx supports work-life balance and provides opportunities for ongoing professional development. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.

Source:  workable View original post

Location
Madison, NJ, USA
Show map

workable

You may also like

Workable
Quality Assurance (QA) Intern for Browser-based Video Surveillance System
IPConfigure is seeking a talented WA Intern to join our team and assist in the development of our Video Management System.  NOTE: This is an on-site internship at our Norfolk, VA headquarters. Key responsibilities: Develop and execute test cases, and test scripts to ensure the quality and reliability of our software products. Conduct thorough regression testing when across various platforms, including Linux environments. Monitor debugging process results. Collaborate with cross-functional teams to identify and prioritize testing requirements, and communicate test results effectively. Configure and maintain Linux-based testing environments, including virtual machines and containerized environments. Document test procedures, test results, and other relevant information to support quality assurance efforts. Stay updated on industry best practices, tools, and technologies related to software testing and quality assurance. Requirements Requirements: Pursuing Bachelor's degree in Computer Science, Engineering, or a related field. Understanding of software testing principles and methodologies, including manual testing techniques and test case design. Ability to execute test cases, report defects, and assist in regression testing activities under the guidance of senior team members. Eagerness to learn and apply testing best practices, including test planning, test execution, and defect management. Basic understanding of Linux operating system fundamentals. Excellent analytical and problem-solving skills, with a keen attention to detail. Strong analytical skills and the ability to work in a fast-paced environment. Willingness to collaborate with team members and stakeholders to achieve project objectives and deliver high-quality software products. Demonstrated ability to adapt to new technologies, tools, and methodologies quickly and effectively. Preferred Qualifications: Experience in software testing and quality assurance roles or Internship or academic projects related to software testing, quality assurance, or software development. Familiarity with automation testing tools (e.g., Selenium, Jenkins). Familiarity with version control systems such as Git and collaborative development workflows Exposure to agile software development methodologies (e.g., Scrum, Kanban) and agile testing practices. Basic proficiency in at least one programming language (e.g., Python, Java, or JavaScript), with the ability to write simple scripts or programs. Benefits Benefits: Hands-on experience working on a real-world project in a supportive and collaborative environment. Opportunity to learn from experienced professionals in the field of software QA. Flexible work hours. Potential for future full-time employment or recommendation for other opportunities within the company. $15/hour. IPConfigure, Inc. provides equal employment opportunities to all qualified persons and administers all aspects and conditions of employment without regard to race, religion, color, sex, gender, sexual orientation, pregnancy, age, national origin, ancestry, physical or mental disability, severe/morbid obesity, medical condition, military or veteran status, genetic information, marital status, ethnicity, alienage or any other protected classification, in accordance with applicable federal, state, and local laws.
Norfolk, VA, USA
$15/hour
Craigslist
$21.00 - $21.00/ HR Warehouse Delivery Driver (Arlington, WA)
Centerline is your one access point to limitless driving opportunities.  Our job is to connect you with safe, rewarding work at top companies while maintaining your flexibility and work/life balance.                                                                        Click to Apply Now What you’ll get: • Pay rate is $21.00 -$21.00/ HR • Eligibility for health benefits, including medical, dental, and vision • Multiple job opportunities with just one application – our truck drivers have the opportunity to work for multiple Fortune 1000 companies What you’ll need: • 6 months of delivery driving experience • Valid driver’s license • Ability to pass a drug screen • No DUI/DWI convictions that are less than 5 years • No more than 2 moving violations in the previous 3 years OR no more than 1 moving violation and 1 accident in the last 3 years • 22 years of age or older What you’ll do: • Operate a Van safely • Hauling: Wine and spirits • Freight Handling: Pallet jack, Hand truck, Forklift • Perform pre-and post-trip inspections • Keep equipment clean and presentable • Verify paperwork for completeness and accuracy • Schedule is Monday through Friday • Shift start time is 7:00 AM Call a Centerline Recruiting Manager now at 855-290-3385 for more information about this opportunity. The pay range outlined herein is a good-faith estimate based on factors such as relevant skills, experience, education, training, geographic location, and other considerations permitted by law. An employee’s pay history will not be a contributing factor where prohibited by local law. Other compensation includes referral bonus opportunities. Learn more at https://www.centerlinedrivers.com/drivers/referral-program/. In addition to monetary compensation, we offer a competitive benefits package that includes medical, dental, vision, life and AD&D, short-term disability, critical illness, accident, and hospital indemnity. More information can be found at https://flimp.live/TrueBlueAssociates. At Centerline, we value and respect the drivers we put to work. In fact, we built our entire driver culture around a simple concept: Respect the Drive. You will earn incentives, recognition, and other great rewards through this program. Learn more about our recognition programs by visiting our Respect the Drive page at https://www.centerlinedrivers.com/respectthedrive/. Our goal is to help CDL drivers find the job they have always wanted. Whether it is competitive pay, local routes, or a work schedule that fits your lifestyle, Centerline is committed to finding the right job for you. Our truck drivers have the opportunity to work for multiple Fortune 1000 companies, locate temporarily in new markets, or work for a single customer full-time. Centerline offers you the type of driving job that fits your needs. Applications are accepted on an ongoing basis unless a deadline is otherwise stated. We will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Los Angeles Fair Chance Ordinance No. 184652. If you need more information or wish to report a violation of this ordinance, please contact the Department of Public Works (DAA), Bureau of Contract Administration. We are an equal opportunity employer, and all drivers will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity, or any other characteristic protected by law. We consider qualified applicants with arrest and conviction records in accordance with applicable law. TrueBlue, Inc. and its brands welcome and encourage applications from candidates with disabilities. Accommodations are available on request for candidates to take part in the selection process. If you require disability-related accommodation during the recruitment process, please contact your Recruiter or Employee Relations at HR-Advice@trueblue.com or 1.800.610.8920. TrueBlue, Inc. and its brands will consult with all applicants who request disability-related accommodation during the recruitment process to ensure that the accommodation provided considers the applicant’s individual accessibility needs. Reference: #460443 Related Terms:  cdl, commercial driver's license, regional, clase a, los conductores de Clase A, CDL license, CDL training, cdl training program, cdl school, cdl jobs, truck driving opportunities, trucking company, student truck drivers, Class A truck driver, class A cdl, semi driver, company truck driver, transport, trucking jobs, cdl truck driver training, truck driver schools, otr truck drivers, hiring truck drivers, company paid training, transportation jobs, relief fleet, truck driving school, truck driver school, truck driving training, truck driver training, trucking school, training for truck drivers, Over the road, team, Freight, OTR, O T R, O.T.R., Company Driver, Transportation, Safe, Semi, Cargo, DOT, D.O.T., Tractor Trailer, Commercial Driver's License, CDL, C D L, Trucking, Truck Driver, Transportation, OTR, Logistics, Income, License, CDL Class A, Delivery, Long Haul, Travel, Great Opportunity, Start your Career, Great Pay, Training, Great benefits, Program, CDL Truck Driver Training, Chauffer, Class A, Class A CDL, Class A Truck Driver, Company Paid Training, Company Truck Driver, Delivery, Delivery Driver, Distribution, Driver, Drivers, Driving, Entry Level, Hiring Truck Drivers, Logistics, OTR Truck Drivers, Over the Road, Route, Semi Driver, Shipping, Student Truck Drivers, Training for Truck Drivers, Transport, Transportation, Transportation Jobs, Truck, Truck Driver, Truck Driver School, Truck Driver Schools, Truck Driver Training, Truck Driving Opportunities, Truck Driving School, Truck Driving Training, Trucking Company, Trucking Jobs, Trucking School, Vehicle, training, job training, on the job training, paid training, job placement, military, veteran
8404 207th St NE, Arlington, WA 98223, USA
$21/hour
Workable
Night Manager
Are you looking for a part-time evening position with a flexible schedule? If you have management experience and good communication skills, you'll want to check out this job at City Wide Facility Solutions! City Wide Facility Solutions, the nation's leading sales and management company in the building maintenance industry, provides solutions to a wide range of issues clients face at their facilities. We offer competitive pay within a collaborative and energizing culture. Position Summary: The Night Manager at City Wide Facility Solutions plays a critical role in overseeing the quality of our cleaning operations during night shifts. This position entails managing relationships with Independent Contractors (IC), ensuring contract compliance, and maintaining high standards of service that meet client expectations. Key Responsibilities: Review and assess the effectiveness of cleaning operations based on client feedback and contractual obligations. Develop strong working relationships with Independent Contractors to foster collaboration and ensure adherence to City Wide’s standards. Conduct regular inspections of facilities to ensure compliance with operational guidelines and client specifications. Facilitate communication between field teams and management to report on daily operations and any urgent matters that arise. Address customer concerns and complaints promptly and effectively to ensure client satisfaction. Oversee the execution of City Wide’s policies related to new client starts and complaints. Prepare and submit nightly reports summarizing the day’s activities, observations, and issues requiring follow-up. Perform any additional duties as necessary to support facility operations and the management team. Requirements High school diploma or equivalent experience. Minimum of 3 years of experience in management or supervisory roles, preferably in facility maintenance or cleaning services. Strong organizational skills with the ability to prioritize tasks and meet deadlines. Excellent communication and interpersonal skills, capable of building relationships with clients and contractors. Detail-oriented with a commitment to quality and operational excellence. Proficient in Microsoft Office Suite and other relevant software. Ability to work independently and make sound decisions in a fast-paced environment. Safety Sensitive: This position is Safety Sensitive. If you are selected for this position, you will need to successfully complete a pre-employment drug screen and background check. Benefits Compensation: Hourly wage of $15-$17/hour based on experience. Mileage reimbursement up to $600/month. Schedule: 20-25 hours per week; may be able to turn into full-time at a later date. The assigned evenings to work are flexible; most of our Night Managers work Sunday - Thursday evenings. The assigned work hours are flexible, somewhere between 5:00 pm – 2:00 am. Many of our Night Managers work 8:00 pm - 1:00 am.  
Shawnee, OK, USA
$15-17/hour
Craigslist
Truck Driver - Hiker/Vehicle Transporter/CDL - Part Time (Everett)
Position Summary: Penske Truck Leasing in North Everett seeks highly motivated and qualified applicants to fill the unique position of Hiker (Vehicle Transporter/Truck Driver). This position is responsible for vehicle delivery and returning vehicles to Penske locations and Penske customers. Primarily, this position moves our box trucks up to 26’ and for CDL Class A will include tractors and trailer movement. Position may also provide assistance to the service department to deliver parts and equipment. This is a casual/on-call part-time truck driving job that is perfect for licensed CDL Class B or CDL Class A drivers seeking supplemental income and looking to work anywhere from 0 to 25 hours a week based on business needs. Major Responsibilities: • Follow appropriate safety procedures while driving trucks to destination of Penske location or customer locations • Check vehicles to ensure that mechanical, safety, and emergency equipment is in good working order, report to location manager if any issues are found • Obtain receipts or signatures for delivered goods and collect payment for services when required • Report vehicle defects, accidents, traffic violations, or damage to the vehicles • Other projects and tasks as assigned by supervisor Qualifications Qualifications: • 2 years of driving experience required • 2 years of a clean DMV motor vehicle record required • CDL Class B license required • CDL Class A license preferred • Ability to read and follow written instructions is required. • Ability to work independently, customer service skills, organizational skills, and a positive attitude are required • In order to be compliant with federal law (49 C.F.R. 391.11(b)(2)), this role requires English language proficiency • Regular, predictable, full attendance is an essential function of the job • As this position requires driving Penske and customer vehicles, it is regulated by the DOT and requires a current driver qualification file to be maintained as required by the role. The driver qualification file includes: an annual motor vehicle records (MVR) check, a successfully completed DOT Physical, and Safety Performance History records request from prior employers in the last 3 years. Additionally, CDL holders will have a DOT Drug Screening within 30 days of start and subject to a FMCSA Clearinghouse review. • Willingness to travel as necessary, work the required schedule, work at the specific location required, complete Penske employment application, submit to a background investigation (to include past employment, education, and criminal history) and drug screening are required. This position is regulated by the Department of Transportation or designated as safety sensitive by the company, and the ability to work in a constant state of alertness and in a safe manner is required. Associates must have the ability to accept responsibility for their own safety, as well as the safety of others. Physical Requirements: -The physical and mental demands described here are representative of those that must be met by an associate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. -The associate must be able to see and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus. -While performing the duties of this job, the associate will be required to move frequently, stand, walk, and sit. The associate is frequently required to use hands to touch, handle, and feel, and to reach with hands and arms. The associate must be able to regularly lift and/or move up to 50lbs/23kg and occasionally lift and/or move up to 100lbs/45kg. -The associate must be able to legally operate a motor vehicle and safely and frequently enter/exit the vehicle as well as the rear cargo area. Salary: Class A $23.00/hr + Shift Differential When Applicable Being part-time, this role will not be eligible for benefits but will have access to PTO accruals and some minor benefits offered at Penske. Penske is an Equal Opportunity Employer. If interested, please apply online at https://ad.doubleclick.net/ddm/clk/614237255;421990839;p?https://track.talentbrew.com?jobmediaid=693731&typeid=1
2132 22nd St, Everett, WA 98201, USA
$23/hour
Workable
Quality Control Inspector
Thorlabs is pleased to play a role in advancing science through the components, instruments, and systems we design and manufacture. We believe that science and innovation have great potential to improve the world around us and are committed to advancing photonics (i.e., light-based) technologies that positively impact our customers, employees, and communities. Via educational outreach and more sustainable business practices, we continuously invest in a brighter future. We recognize that each of our employees is a unique individual with the ability to contribute to our success and seek to find great people who will thrive in our fun, fast-paced culture. This position effectively assures vendor & manufacturing compliance to Thorlabs ISO9001 quality standards protecting customers. Inspectors perform visual and dimensional inspection of precision parts and make quick, accurate pass/fail decisions on many types of optics including filters, mirrors, crystals, prisms, and lenses as well as mechanical components used in conjunction with optical components. Visual surface quality inspections are often performed under 100 watt bulb in low lit room. Although the location of the position is in Newton, NJ, from time to time it may be required to undertake duties at other Thorlabs locations.    Essential Job Functions include the following, but are not limited to: Introduction to visual and mechanical measurement of parts using metrology devices such as eye loupes, microscopes, calipers, micrometers, and indicators. Identify non-conformances through specified inspection methods. Ability to perform extremely detailed visual inspections on intricate and delicate parts occasionally performed under microscopes. Inspections are performed efficiently, with attention to detail. Low friction interface to peers/vendors/others in interaction with regards to inspection. Inspection of products against manufacturing prints. Handle and Clean Specialty Fiber Optics, Precision Optics, and mechanical components. Maintain proper records in our Manufacturing Database. Ask questions when instructions are not understood or clear. Comply with the company safety program and maintain a clean and organized work area.   In addition to the essential functions and duties listed above, all positions are also responsible for: Meeting company standards pertaining to quantity and quality of work performed on an ongoing basis, performing all work-related tasks in a manner that is in compliance with all Company policies and procedures. Adhering to Company policies, procedures, and directives regarding standards of workplace behavior in completing job duties and assignments. The Company retains the right to change or assign other duties to this position.   Physical Activities:    Work may be active, could stand or sit for long durations and/or perform repetitious work at times. The employee may lift or move objects up to 20 pounds. Employees must grasp, manipulate, or assemble parts and components that are often very small. The noise level in the work environment is usually moderate, however, may be noisy at times. Must be able to wear appropriate clothing and personal protective equipment such as but not limited to masks, glasses, gloves, and specialty garments. The required PPE and training allow for the safe handling and processing of chemicals like adhesives, lubricants and solvents, and safe operation of job-related equipment and tools.     Requirements Experience: 1 year experience in a similar position preferred. Education: High School Diploma or equivalent work experience. Specialized Knowledge and Skills: Ability to learn, understand, and effectively apply sampling plans. Good verbal and written communication skills to operate in both individual and team environments. Capable of reading mechanical drawings and interpret dimensional tolerances. Adaptable to process and procedure changes. Ability to meet department standards for productivity and quality. Computer literacy using Microsoft product suite is desired. Must have the ability to cross train in all areas of the department, including but not limited to visual and dimensional inspection, data entry. High attention to detail. Hourly pay range for this position is $18.00 - $23.65 d.o.e. Thorlabs values its diverse environment and is proud to be an Equal Employment Opportunity/Affirmative Action Employer.  All qualified individuals will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age or veteran status. Job descriptions are not intended as and do not create employment contracts.  The organization maintains its status as an at-will employer.  Employees can be terminated for any reason not prohibited by law. Benefits Thorlabs offers a complete benefits package that includes medical, dental and vision insurance, company paid life insurance, a generous PTO package, a 401(k) plan, and tuition reimbursement just to name a few.
Newton, NJ, USA
$18/hour
Craigslist
Truck Driver - Hiker/Vehicle Transporter/CDL - Part Time (Everett)
Position Summary: Penske Truck Leasing in North Everett seeks highly motivated and qualified applicants to fill the unique position of Hiker (Vehicle Transporter/Truck Driver). This position is responsible for vehicle delivery and returning vehicles to Penske locations and Penske customers. Primarily, this position moves our box trucks up to 26’ and for CDL Class A will include tractors and trailer movement. Position may also provide assistance to the service department to deliver parts and equipment. This is a casual/on-call part-time truck driving job that is perfect for licensed CDL Class B or CDL Class A drivers seeking supplemental income and looking to work anywhere from 0 to 25 hours a week based on business needs. Major Responsibilities: • Follow appropriate safety procedures while driving trucks to destination of Penske location or customer locations • Check vehicles to ensure that mechanical, safety, and emergency equipment is in good working order, report to location manager if any issues are found • Obtain receipts or signatures for delivered goods and collect payment for services when required • Report vehicle defects, accidents, traffic violations, or damage to the vehicles • Other projects and tasks as assigned by supervisor Qualifications Qualifications: • 2 years of driving experience required • 2 years of a clean DMV motor vehicle record required • CDL Class B license required • CDL Class A license preferred • Ability to read and follow written instructions is required. • Ability to work independently, customer service skills, organizational skills, and a positive attitude are required • In order to be compliant with federal law (49 C.F.R. 391.11(b)(2)), this role requires English language proficiency • Regular, predictable, full attendance is an essential function of the job • As this position requires driving Penske and customer vehicles, it is regulated by the DOT and requires a current driver qualification file to be maintained as required by the role. The driver qualification file includes: an annual motor vehicle records (MVR) check, a successfully completed DOT Physical, and Safety Performance History records request from prior employers in the last 3 years. Additionally, CDL holders will have a DOT Drug Screening within 30 days of start and subject to a FMCSA Clearinghouse review. • Willingness to travel as necessary, work the required schedule, work at the specific location required, complete Penske employment application, submit to a background investigation (to include past employment, education, and criminal history) and drug screening are required. This position is regulated by the Department of Transportation or designated as safety sensitive by the company, and the ability to work in a constant state of alertness and in a safe manner is required. Associates must have the ability to accept responsibility for their own safety, as well as the safety of others. Physical Requirements: -The physical and mental demands described here are representative of those that must be met by an associate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. -The associate must be able to see and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus. -While performing the duties of this job, the associate will be required to move frequently, stand, walk, and sit. The associate is frequently required to use hands to touch, handle, and feel, and to reach with hands and arms. The associate must be able to regularly lift and/or move up to 50lbs/23kg and occasionally lift and/or move up to 100lbs/45kg. -The associate must be able to legally operate a motor vehicle and safely and frequently enter/exit the vehicle as well as the rear cargo area. Salary: Class A $23.00/hr + Shift Differential When Applicable Being part-time, this role will not be eligible for benefits but will have access to PTO accruals and some minor benefits offered at Penske. Penske is an Equal Opportunity Employer. If interested, please apply online at https://ad.doubleclick.net/ddm/clk/614237255;421990839;p?https://track.talentbrew.com?jobmediaid=693729&typeid=1
2132 22nd St, Everett, WA 98201, USA
$23/hour
Cookie
Cookie Settings
Our Apps
Download
Download on the
APP Store
Download
Get it on
Google Play
© 2025 Servanan International Pte. Ltd.