Medical Device Quality Assurance Engineer (Part-Time Contract)

Position Title:

Medical Device Quality Assurance Engineer (Part-Time Contract) Position Summary We are seeking a mid-level Medical Device Quality Assurance Engineer to support quality system implementation, design control compliance, risk management activities, and regulatory readiness for Class II medical device development programs. The Quality Assurance Engineer will play a key role in assessing existing documentation and processes, supporting quality system development and remediation efforts, and leading or assisting with the implementation of a Quality Management System (QMS) aligned with

FDA 21 CFR

Part 820 (QMSR), ISO 13485, and

ISO 14971

requirements. Working collaboratively with quality, regulatory, engineering, clinical, and external stakeholders, the Quality Assurance Engineer will support activities related to Design History File (DHF) development and remediation, Risk Management File development, supplier controls, CAPA, complaint handling, document control, design reviews, quality system implementation, and the planning and execution of on-site supplier audits in accordance with FDA QMSR and

ISO 13485

requirements. This position is ideal for an individual with experience in medical device quality systems, design controls, risk management, supplier quality management, and product development who can contribute independently while collaborating within a cross-functional team environment. Key Responsibilities

• Review existing quality system, design control, and risk management documentation for compliance with

FDA QMSR, ISO

13485, and

ISO 14971

requirements.

• Conduct gap assessments of quality records, design documentation, supplier controls, manufacturing documentation, and post-market processes.
• Support development and execution of quality system remediation and compliance improvement activities.
• Assist in the development, reconstruction, maintenance, and organization of Design History File (DHF) documentation, including design inputs, design outputs, traceability matrices, verification and validation records, and design review documentation.
• Support development and maintenance of Risk Management Files in accordance with ISO 14971, including hazard analyses, risk assessments, risk controls, and risk management traceability.
• Prepare, update, and maintain quality system procedures, SOPs, templates, forms, and records supporting product development and quality operations.
• Coordinate and document formal hardware and software design reviews in accordance with established design control procedures.
• Support implementation and maintenance of QMS processes, including document control, CAPA, supplier management, complaint handling, internal and supplier audits, management review, and change control.
• Conduct supplier quality management activities, including supplier qualification, oversight, and monitoring, issuance and management of supplier corrective actions (SCARs), maintenance of quality agreements, and execution of on-site supplier audits in accordance with FDA QMSR and

ISO 13485

requirements.

• Participate in product testing gap assessments and assist with compilation of supporting verification, validation, and standards compliance documentation.
• Assist with labeling, UDI, and other quality compliance documentation as required.
• Prepare quality reports, records, and supporting documentation to support inspection readiness and ongoing compliance activities.
• Lead in continuous quality improvement initiatives.
• Collaborate with engineering, regulatory, clinical, and external vendor teams to ensure documentation remains accurate, traceable, and compliant throughout the product lifecycle. Qualifications
• Bachelor's degree in Engineering, Quality, Life Sciences, or a related technical discipline.
• 3-7 years of quality assurance or quality engineering experience within the medical device industry.
• Working knowledge of

FDA 21 CFR

Part 820/QMSR, ISO 13485, and

ISO 14971

requirements.

• Experience supporting design controls, DHF documentation, risk management, CAPA, complaint handling, document control, QMS auditing and quality system processes.
• Familiarity with design verification and validation documentation and traceability requirements.
• Experience supporting Class II medical devices; experience with hardware and software medical devices is preferred.
• Familiarity with FDA Pre-Submission and 510(k) documentation requirements is desirable.
• Strong technical writing, documentation, organizational, and communication skills.
• Ability to work independently in a remote, project-based environment while effectively collaborating with cross-functional teams.
• ASQ Certified Quality Engineer (CQE) or related certification is a plus. Engagement Structure
• Part-time contract position
• Estimated commitment: 30-40 hours per month
• Remote work with periodic team meetings as required
• Potential travel to vendor sites
• Project-based engagement with potential extension based on program needs