Quality Engineer — Medical Device Manufacturing (SPC & CAPA)

Exemplar Global; Sault Ste. Marie (MI); On-site; USD 85,000 - 95,000; Full time

Benefits offered by this job

BCBS health, dental, and vision

401(k) match

Paid time off

Relocation lump sum

Job summary

Exemplar Global is seeking a Quality Engineer to ensure the quality of high-precision surgical products in a growing medical device environment in Sault Ste. Marie, MI.

The role focuses on developing and maintaining inspection plans, supporting MRB and new product releases, leading CAPA investigations, validating processes and products, and performing Gage R&R and measurement system analyses to ensure regulatory compliance and customer satisfaction.

Qualifications

• Bachelor’s degree in Engineering or equivalent.
• Experience with precision measuring equipment and Gage R&R.
• Strong analytical skills and attention to detail.
• Experience with internal and external customers.

Responsibilities

• Support quality across medical device manufacturing operations.
• Develop and maintain inspection plans for new and existing products.
• Participate in MRB and new product release reviews.
• Lead CAPA investigations.
• Support process and product validation.
• Develop PFMEAs and Control Plans.
• Run process capability studies and SPC programs.
• Perform Gage R&R and measurement system analysis.
• Program and support inspection equipment.
• Conduct supplier audits and support customer audits.
• Write work instructions and train employees on quality standards.

Skills

Experience with precision measuring设备

Experience working with internal and外部

Strong analytical skills and attention

Six Sigma

Lean Manufacturing

Education

Bachelor’s degree in Engineering

Tools

Gage R&R

SPC programs

PFMEAs

Control Plans

Job description

Exemplar Global is seeking a Quality Engineer to ensure the quality of high-precision surgical products in a growing medical device environment in Sault Ste. Marie, MI.

The role focuses on developing and maintaining inspection plans, supporting MRB and new product releases, leading CAPA investigations, validating processes and products, and performing Gage R&R and measurement system analyses to ensure regulatory compliance and customer satisfaction.