Senior Design Control Engineer for IVD Medical Devices

QUEST DIAGNOSTICS INC; Marlborough (MA); On-site; USD 105,000 - 125,000; Full time

Benefits offered by this job

Day 1 Medical, supplemental health, dental & vision

401(k) with company match

Flexible Spending Accounts

Career advancement opportunities

Job summary

QUEST DIAGNOSTICS INC is looking for a Staff Design Quality Engineer in Marlborough, Massachusetts. You will oversee quality for complex IVD medical devices, ensuring compliance with regulatory standards and guiding cross-functional teams.

The ideal candidate will have over 8 years of quality engineering experience and a Bachelor's degree in Engineering or Life Sciences. Opportunities for career advancement and a comprehensive benefits package are provided.

Qualifications

• 8+ years of experience in design quality or quality engineering within medical device or IVD environments.
• Deep technical knowledge in design controls, risk management, and validation strategies.
• Strong knowledge of FDA QMSR and ISO standards.

Responsibilities

• Provide quality oversight for complex IVD product development.
• Review design control deliverables and guide cross-functional teams.
• Lead quality evaluation of major design changes and validations.

Skills

Technical judgment

Documentation quality

Problem-solving

Education

Bachelor's degree in Engineering, Life Sciences, or related technical field

Job description

QUEST DIAGNOSTICS INC is looking for a Staff Design Quality Engineer in Marlborough, Massachusetts. You will oversee quality for complex IVD medical devices, ensuring compliance with regulatory standards and guiding cross-functional teams.

The ideal candidate will have over 8 years of quality engineering experience and a Bachelor's degree in Engineering or Life Sciences. Opportunities for career advancement and a comprehensive benefits package are provided.