Design Quality Engineer

We are seeking a Design Quality Engineer to support product development, validation, and lifecycle management activities within a medical device environment. This role will be responsible for ensuring compliance with design control requirements, supporting product validation efforts, maintaining Design History File (DHF) documentation, and collaborating with cross-functional teams and external suppliers to deliver high-quality, compliant products., * Support product validation (PV) activities, including review and approval of validation protocols, reports, and related deliverables.

• Collaborate with suppliers and contract manufacturers to review technical documentation, engineering drawings, control plans, and validation packages.
• Ensure design and process changes comply with applicable quality system requirements and regulatory standards.
• Participate in risk management activities, including FMEA, risk assessments, hazard analysis, and mitigation planning.
• Develop, review, and maintain Design History File (DHF) documentation to ensure accuracy, completeness, and regulatory compliance.
• Create and manage traceability matrices linking design inputs, outputs, verification, and validation activities.
• Support design reviews and ensure proper execution of design control processes.
• Partner with R&D, Manufacturing, Regulatory Affairs, and Quality teams throughout the product lifecycle.
• Assist with change control activities, ensuring appropriate documentation, approvals, and implementation.
• Provide support during audits, inspections, and compliance reviews.

• Bachelor’s degree in Engineering or a related technical discipline.
• 3+ years of Quality Engineering experience within the medical device industry.
• Strong knowledge of Design Controls and applicable regulations, including FDA 21 CFR Part 820 and ISO 13485.
• Experience supporting Product Validation (PV) activities.
• Experience working with external suppliers, contract manufacturers, and technical documentation reviews.
• Ability to interpret engineering drawings, specifications, and control plans.
• Hands-on experience with risk management tools such as FMEA and risk assessments.
• Experience developing and maintaining DHF documentation and traceability matrices.
• Strong technical writing, documentation, and organizational skills.
• Excellent communication and cross-functional collaboration abilities.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.