Design Quality Engineer

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Position Objective
The Design Quality Engineer will be instrumental in driving the quality assurance aspects of product design & development, from concept through to market release. This role requires a seasoned professional with a deep understanding of medical device regulations, standards, and quality management systems (QMS). A successful candidate will collaborate closely with cross-functional teams to ensure that design controls, risk management, and validation activities are effectively executed and documented in accordance with regulatory requirements.

Responsibilities

• Lead the quality engineering activities in product development projects, ensuring compliance with ISO 13485, FDA QSR/QMSR, EU MDR and other applicable regulations and standards.
• Facilitate the application of design controls, including design and development planning, input, output, review, verification, validation, and transfer activities.
• Ensure that development activities follow design control requirements (demonstrated via Traceability Matrix), product is tested per applicable standards, ER/GSPR are met per the MDD/MDR, and product is properly transferred to manufacturing per applicable specifications.
• Champion risk management activities according to ISO 14971, ensuring risks are identified, evaluated, and mitigated throughout the product lifecycle.
• Collaborate with R&D, regulatory affairs, manufacturing, and other departments to ensure quality and regulatory requirements are integrated into the product development process.
• Author, review and/or approve technical documentation, including, but not limited to, design specifications, DFMEA, PFMEA, UFMEA, verification & validation protocols/reports, product labelling, equipment qualifications, and design changes, ensuring they meet regulatory and quality requirements.
• Lead complex root cause analysis and problem-solving activities related to product design & development and risk management.
• Support continuous improvement initiatives by identifying opportunities to enhance the QMS, particularly in areas related to design & development and risk management.
• Participate in internal and external audits and lead the resolution of any findings related to product design and development.
• Serve as a subject matter expert on Quality-related matters (e.g. risk management, human factors, statistical analysis) in their application to design controls, and provide guidance and training to others, as necessary.
• Provide expert interpretation of current and emerging regulations, standards and guidance impacting the design & development and risk management process.
• Assist in the preparation of submissions for regulatory agencies.
• Performs other duties assigned as needed.

Critical Success Factors

• In-depth knowledge of FDA QSR/QMSR, MDSAP, EU MDD/MDR, ISO 13485, ISO 14971, ISO 62366, ISO 15223, and other relevant standards and regulations highly preferred.
• ASQ Certification (CQE, CRE, or similar) is highly desirable.

Qualifications

• Bachelor's degree in Biomedical, Mechanical, Industrial, Materials or related Engineering discipline.

Experience

• Minimum of 3 years of experience in the medical device industry, with a strong focus on quality engineering and regulatory compliance.

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