Medical Documentation Specialist

Coordinates design review meetings to review all quality aspects of new products. Interfaces with Product Development Engineers to ensure quality considerations during the concept stage. •Support Design Control activities by ensuring compliance with FDA and international regulations. •Lead and participate in Design Failure Modes and Effects Analysis (DFMEA) and risk assessments. •Review protocols and participate in planning to ensure alignment with product requirements. •Participate in protocol review and support testing strategy, ensuring robust verification and validation processes. •Support Design Control activities by ensuring compliance with FDA and international regulations. •Develops various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures and operator self-inspection procedures. •Works with other Quality Engineers and the Metrology Lab personnel on the development of all product gaging. •Support the development and review of process and equipment validation/qualification (IQ/OQ/PQ) and MSA of internal processes. •Works with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems. Also, assists each of these groups with capability studies and the application of statistical quality control. •Interfaces with Manufacturing Engineers to review processes for new products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable. •Assists with complaint investigation and documentation interfaces with Regulatory Affairs to support UL, IEC, and FDA submissions. Participates in internal audits conducted by internal employees and regulatory agencies. •Develop and execute supplier qualification processes, including supplier contracts and PPAPs. •Manage and drive timely resolution of nonconformances (NCs) and corrective & preventive actions (CAPAs). EDUCATION and/or EXPERIENCE: •Bachelor’s degree in Engineering, Quality, or a related field (Master’s preferred). •5+ years of experience in medical device quality engineering or a related field. •Strong knowledge of ISO 13485, FDA QSR (21 CFR Part 820), EU MDR, and risk management (ISO 14971). •Experience with Design Control, Process Validation, CAPA, and Supplier Quality. •Proficiency in statistical analysis tools (Minitab, JMP, Excel) /and problem-solving methodologies (8D, DMAIC). •Certified Quality Engineer (CQE) or Six Sigma certification is a plus. KEY COMPETENCIES: (Leadership skills/behaviors) Building Strategic Working Relationships-Developing and using collaborative relationships to facilitate the accomplishment of work goals. Quality Orientation-Accomplishing tasks by considering all areas involved, no matter how small; showing concern for all aspects of the job; accurately checking processes and tasks; being watchful over a period of time. Decision Making- Identifying and understanding issues, problems, and opportunities; comparing data from different sources to draw conclusions; using effective approaches for choosing a course of action or developing appropriate solutions; taking action that is consistent with available facts, constraints, and probable consequences. Performance/Work Standards-Setting high standards of performance for self and others; assuming responsibility and accountability for successfully completing assignments or tasks. (Flawless Execution of the Basics). Information Monitoring- Setting up ongoing procedures to collect and review information needed to manage an organization or ongoing activities within it.

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Immediate opening is available for full-time Mechanical Inspectors, 1st Class and 2nd Class for Production and Final Quality Inspection in Farmingdale. NY. Responsibilities include monitoring, measuring, and documenting the characteristics of products as compared to product requirements and prevent non-conforming product. This position will work with machined and fabricated metal products at various stages in our manufacturing processes including final Quality Inspection. We are seeking individuals with excellent interpersonal skills and operational expertise to join our production team.  Essential Duties and Responsibilities include the following: - Monitor and measure the characteristics of products at appropriate stages of product realization. - Document and analyze the conformity of product to required specifications - Cooperate with manufacturing to prevent non-conforming product and continuously improve processes. Supervisory Responsibilities: This job has no supervisory responsibilities. Balances team and individual responsibilities; Gives and welcomes feedback; Puts success of team above own interests. - Written Communication - Excellent command of the written English language; Writes clearly and informatively; Varies writing style to meet needs; comprehends and applies proper email etiquette; presents numerical data effectively; able to read and interpret complex written information (customer specification manuals, contracts, etc). - Problem Solving -- identifies and resolves problems in a timely manner; gathers and analyzes information and data skillfully; develops alternative solutions; works well in group problem solving situations. Requirements Education and/or Experience: A high school diploma or equivalent. The preferred candidate will have: - Experience with Measuring and Testing Equipment including CMM equipment. - Ability to read and interpret part drawings, product specifications, and other related documentation. Must understand Geometric Dimensioning and Tolerances (GD&T) to product inspection Qualifications / Requirements: - Must be a detail-oriented, communicator, able to prioritize tasks and able to work under pressure with multiple deadlines. - Must be able to use all standard measuring instruments and CMM equipment. - While performing the duties of this Job, the employee is regularly required to sit; use hands to type, handle and feel. Employees must be able to communicate effectively through talking and listening. The employee is occasionally required to stand; walk, and reach, lift and carry objects weighing up to 25 lbs with hands and arms.

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MPF Federal, is seeking a Quality Assurance Specialist. This position requires familiarity with the Department of Energy, specific Hanford Site (Richland, Washington) knowledge and experience preferred. Compensation:  $83,000.00 - $145,000. Primary duties include but are not limited to: Maintenance, implementation and effectiveness of the RL and ORP quality assurance programs. Assessment of the prime contractors’ quality assurance program implementation and effectiveness. Review of prime and sub-contractor activities and documents with respect to the proper flow down of the applicable quality assurance requirements. Conducting and/or reviewing documentation of quality assurance receipt inspections on- site. Monitoring prime and sub-contractor activities and documentation for compliance with contract statement of work requirements. Document reviews Assist with: Quality Assurance support plans and documents. Quality Assurance Audit Reports. Technical Surveillance Reports. Operational Awareness Reports. Management Assessment/Independent Assessment Reports. Quality Assurance Vulnerability Assessment Reports. Work products shall be thorough, accurate, appropriately documented, and comply with established criteria. Ensure that duties are performed in a competent and professional manner. Submit a weekly report to the technical monitor addressing work accomplished, and deliverable progress. Schedule: Monday to Friday Work Location: In person Requirements Minimum Qualifications: Grade E2 Bachelor's degree in a related field of study 4-7 years' experience Grade E3 Bachelor's degree in a related field of study 8-11 years' experience Grade E4 Bachelor's degree in a related field of study 12-14 years' experience   Requirements for all Grades: Experience in commercial, or government, nuclear quality program planning, development, and implementation. Experience as a Lead or Senior Quality Engineer or Specialist. Prior or current NQA-1 auditor qualification. Experience in performing surveillances/audits/assessments with respect to verifying contract specifications. Experience in plant testing, turnover and plant operations. Experience with operational readiness reviews. Excellent communications skills. Proficient in Microsoft Office Word, Excel, Project, Visio, and Power Point. U.S. Citizenship Benefits MPF Federal offers a competitive benefits package including medical/dental/vision, short-and-long-term disability, life insurance, 401(k) with immediate vesting in the employer match and more. MPF Federal is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status or on the basis of disability.   Benefits: 401(k) Dental insurance Health insurance Life insurance Vision insurance

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