Product Quality Engineer

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 The Product Quality Engineering team at OrganOx is a technical quality engineering team responsible for monitoring, understanding, and improving product performance of the OrganOx Metra, a Class III medical device. The Product Quality Engineering team works closely with Product Sustaining Engineering and Contracted Suppliers to set in place quality control and management processes for externally built products and componentry, including sterilization and microbiology, supplier management, and contract manufacturing processes. The Product Quality Engineer will have strong hands-on technical skills with an ability to analyze product quality issues and work cross-functionally to solve problems related to product quality. The successful candidate is collaborative, has excellent communication and problem-solving skills, and is passionate about delivering world-class products that make healthcare more accessible, simpler, and safer. 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 flexible, on-site role in our Madison, NJ office. Major Responsibilities Under direction from the Senior Product Quality Engineer and Senior Manager, Product Quality Engineering, the Product Quality Engineer may be responsible for the following: Lead root-cause investigations in response to customer complaints Support hands-on analyses of returned products to identify root causes of failures ·       Support development of investigation criteria and test methods to properly diagnose and root cause field failures   Analyze and trend on product performance data to provide recommendations for product improvements Raise Supplier Corrective Action Reports (SCARs) in response to product performance trends. Support timely closure of SCARs. Work cross-functionally with other engineering teams and contracted suppliers to implement changes in manufacturing and inspection procedures to mitigate field failures. Maintain good working relationships with suppliers to support root cause investigation and failure mitigation efforts ·       Support CAPAs, Escalations, and engineering investigations in response to field quality issues. Participate in the development and review of engineering change orders that impact product quality activities Perform DHR, Service History record, and PFMEA reviews in support of complaint investigations. Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies. Requirements Skills and Experience Experience investigating and resolving SCARS and CAPAs  Strong experience with statistical analysis of data; Experience with Minitab preferred Experience with Six Sigma principles preferred Excellent oral and written communication skills with the ability to communicate with audiences of varying technical skills A strong ability to prepare written technical plans and reports in support of engineering changes, product or process validations, and failure investigations Strong focus on meeting customer needs  Proven ability to work cross functional and within global teams, fostering a culture of high collaboration Ability to be self-driven and solve complex problems independently. Committed to upholding OrganOx values in daily work and decision-making Experience in driving a global quality mindset across teams and geographies Demonstrated strong attention to detail and “do it right the first time” attitude Qualifications Bachelor’s degree in an Engineering discipline (Electrical, Mechanical, Bio-Medical, etc.) or the equivalent work experience is required ·       1-4 years of related hands-on engineering experience in Medical Devices, Pharmaceuticals or other regulated industry is required Excellent technical report writing skills are required Strong Root Cause Analysis, Design of Experiments, and Test Method Development experience as related to complaint investigations is required Strong experience with MS Office Products (Word, Excel, Visio, Project, PowerPoint, Outlook, etc.) is required Prior experience performing complaint investigations preferred A solid understanding of the FDA QSR Quality System Requirements, and the ability to apply the knowledge to comply with goals and objectives is highly preferred Knowledge of electro-mechanical troubleshooting techniques is preferred Familiarity with ISO14971 and associated Risk Management Processes is a plus Six Sigma Green Belt or Black Belt Certification preferred Ability to travel 10-20% (domestically and internationally) #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 $105,000 - $115,000 annually, with a 10% target annual bonus and benefits. At OrganOx, 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.