Quality Engineer - Medical Device | CAPA & SPC Lead

SteveRecruiter, LLC; Sault Ste. Marie (MI); On-site; USD 90,000 - 100,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401k Match

PTO

Job summary

SteveRecruiter, LLC in Michigan is seeking a Quality Engineer to support manufacturing operations, develop inspection plans, and drive process improvements in a regulated medical manufacturing environment.

The role requires 3+ years in quality engineering, collaboration with suppliers and customers, and expertise with measurement systems and CAPA programs. Competitive salary and relocation support offered.

Qualifications

• Bachelors Degree in Engineering required.
• 3+ years of quality engineering in manufacturing preferred.
• Experience with internal and external customers.

Responsibilities

• Support quality activities across manufacturing operations.
• Develop and maintain inspection plans for new and existing products.
• Lead CAPA activities and MRB reviews.
• Develop PFMEA and Control Plans and conduct process capability analysis.
• Support validation activities and supplier quality.
• Train employees on quality procedures and inspection standards.

Skills

Six Sigma

SPC

Lean manufacturing

CAPA

MRB

Process improvement

Education

Bachelors Degree in Engineering

Tools

PFMEA

Control Plans

Gage R&R

Quality documentation

Job description

SteveRecruiter, LLC in Michigan is seeking a Quality Engineer to support manufacturing operations, develop inspection plans, and drive process improvements in a regulated medical manufacturing environment.

The role requires 3+ years in quality engineering, collaboration with suppliers and customers, and expertise with measurement systems and CAPA programs. Competitive salary and relocation support offered.