Quality Engineer – Design Control

• Support Design Control, Sustaining Engineering, and quality-system activities for medical devices
• Assess process gaps, compliance risks, rework, and manufacturing documentation
• Maintain DHF, DMR, DHR, work instructions, and controlled documents
• Support design changes, risk assessments, impact assessments, and change controls
• Support CAPA, process improvements, and quality deliverables
• Collaborate with Design, Manufacturing, Quality, and Regulatory teams
• Ensure proper documentation, traceability, and FDA quality-system compliance
• Identify process gaps and non-standard rework and drive corrective actions
• Support capital equipment and systems engineering activities with a design focus
• 2–3+ years of experience in quality engineering, design control, systems engineering, sustaining engineering, or a related field
• Experience working in the medical device industry or another regulated environment
• Strong understanding of Design Control and Quality Systems
• Experience with change control, risk management, CAPA, and impact assessments
• Experience reviewing and maintaining DHF, DMR, DHR, work instructions, and manufacturing documentation
• Experience supporting design changes and sustaining engineering activities
• Understanding of FDA and applicable medical device quality-system requirements
• Experience identifying process gaps, compliance risks, and documentation issues
• Strong cross-functional collaboration skills with Design, Manufacturing, Quality, and Regulatory teams
• Systems engineering and design-focused experience is preferred
• Experience with capital equipment and quality-system activities is preferred
• Quality Systems
• Medical Device Industry Experience

No employer-provided benefits for this contract position.

We are committed to providing equal employment opportunities to all qualified individuals. We base employment decisions on job-related qualifications, business needs, and other lawful considerations, without regard to any characteristic protected by applicable federal, state, or local law.