Senior Medical Device QA Specialist

Perrigo; Allegan Township (MI); On-site; USD 120,000 - 160,000; Full time

Job summary

Perrigo is seeking a Device Quality and Design Assurance Analyst to provide independent quality leadership for medical device development from concept through market launch. This role ensures design controls, risk management, verification/validation, design transfer, and launch-readiness activities meet regulatory requirements and Perrigo quality objectives.

Collaborating with R&D, Regulatory, Clinical, Operations, and external partners, you will embed quality throughout development and support

Qualifications

• Bachelor's degree in engineering, life sciences, biomedical sciences, Quality, or related technical discipline.
• 7+ years of progressive experience in medical device Quality, design assurance, product development, engineering, regulatory affairs, or a related regulated function, including 4+ years supporting medical device design and development.
• Knowledge of design controls, risk management, verification and validation, design transfer, change control, and product commercialization.
• Working knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, and applicable EU MDR requirements.
• Experience reviewing design and development documentation and participating in formal design reviews or stage-gate decisions.
• Strong written and verbal communication skills.
• Ability to travel independently, including overnight travel, based on business needs.

Responsibilities

• Provide independent Quality oversight for medical device development from concept through market launch.
• Ensure design controls, risk management, verification/validation, and design transfer meet regulatory requirements.
• Collaborate with R&D, Regulatory Affairs, Clinical, Operations, Supply Chain, and external partners to embed Quality throughout development.
• Provide Quality oversight of external development partners, contract manufacturers, laboratories, and critical suppliers.
• Ensure manufacturing processes, testing methods, validation, and transfer before commercial launch.
• Lead or support deviations, nonconformities, investigations, corrective actions, and design changes.

Skills

Design controls

Risk management

Verification and validation

Design transfer

Change control

Regulatory compliance

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in engineering, life sciences, biomedical sciences, quality, or related technical discipline

Job description

Perrigo is seeking a Device Quality and Design Assurance Analyst to provide independent quality leadership for medical device development from concept through market launch. This role ensures design controls, risk management, verification/validation, design transfer, and launch-readiness activities meet regulatory requirements and Perrigo quality objectives.

Collaborating with R&D, Regulatory, Clinical, Operations, and external partners, you will embed quality throughout development and support