Medical Device Quality Assurance Specialist

Perrigouk; Allegan Township (MI); On-site; USD 120,000 - 170,000; Full time

Job summary

Perrigo is seeking a Device Quality and Design Assurance Analyst Quality Assurance to provide independent quality leadership across medical device development from concept to launch. The role interacts with R&D, Regulatory Affairs, Clinical, and Operations to ensure design controls, risk management, and verification/validation meet regulatory requirements.

The candidate will review documentation, manage design transfers, and oversee risk controls while maintaining launch readiness and

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.
• Demonstrated knowledge of design controls, risk management, verification and validation, design transfer, change control, and product commercialization.

Responsibilities

• Provide independent Quality oversight for medical device development from concept through launch, ensuring compliance with regulatory requirements and internal procedures.
• Review and approve design and development documentation, including requirements, specifications, protocols, reports, risk-management files, and validation evidence.
• Partner with R&D, Engineering, Regulatory Affairs, Clinical, Operations, and external partners to ensure quality requirements are embedded throughout development.
• Lead or support deviations, nonconformities, investigations, corrective actions, and change controls in development projects.
• Assist with readiness for regulatory inspections and post-market governance activities.

Skills

Quality leadership

Cross-functional collaboration

Regulatory knowledge

Verbal communication

Education

Bachelor's degree in engineering or related field

Job description

Perrigo is seeking a Device Quality and Design Assurance Analyst Quality Assurance to provide independent quality leadership across medical device development from concept to launch. The role interacts with R&D, Regulatory Affairs, Clinical, and Operations to ensure design controls, risk management, and verification/validation meet regulatory requirements.

The candidate will review documentation, manage design transfers, and oversee risk controls while maintaining launch readiness and