Quality Engineer: CAPA & Process Improvement (Medical Devices)

H.T. Prof Executive Search; Michigan; On-site; USD 80,000 - 110,000; Full time

Job summary

The Quality Engineer will join a growing medical device manufacturer backed by a global organization. This role supports manufacturing operations by developing and maintaining quality systems, driving continuous improvement, and ensuring compliance with regulatory standards.

The ideal candidate has 3+ years in quality engineering, experience with MRB, CAPA, PFMEA, SPC, and a strong ability to analyze processes and collaborate with suppliers and customers to maintain high product quality.

Qualifications

• Bachelor’s degree in engineering required.
• 3+ years of manufacturing quality engineering experience.
• Experience with CAPA, MRB, and change control processes.
• Experience using precision measuring equipment.
• Ability to develop PFMEA and control plans.
• Strong collaboration with suppliers and customers.

Responsibilities

• Support quality activities across manufacturing operations
• Develop and maintain inspection plans for products
• Lead CAPA and MRB processes
• Support process and product validation activities
• Develop PFMEA and control plans
• Conduct process capability and statistical analysis
• Develop SPC programs and perform Gage R&R
• Conduct vendor audits and supplier quality activities
• Train employees on quality procedures

Skills

Process improvement

CAPA

Statistical analysis

Quality systems

Gage R&R

Cross-functional collaboration

Education

Bachelor's degree in engineering

Tools

PFMEA

Control Plans

SPC

Gage R&R

Job description

The Quality Engineer will join a growing medical device manufacturer backed by a global organization. This role supports manufacturing operations by developing and maintaining quality systems, driving continuous improvement, and ensuring compliance with regulatory standards.

The ideal candidate has 3+ years in quality engineering, experience with MRB, CAPA, PFMEA, SPC, and a strong ability to analyze processes and collaborate with suppliers and customers to maintain high product quality.