Design Quality Engineer

Role:
Design Quality Engineer Location

Warsaw, IN & Raynham, MA (Onsite)

6-Month Contract

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.