Quality Engineer - Medical Device Manufacturing

Exemplar Global; Sault Ste. Marie (MI); Sur place; USD 85 000 - 95 000; Plein temps

Avantages offerts par ce poste

BCBS health, dental, and vision

401(k) match

Paid time off

Relocation lump sum

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Experience with precision measuring设备

Experience working with internal and外部

Strong analytical skills and attention

Six Sigma

Lean Manufacturing

Formation

Bachelor’s degree in Engineering

Outils

Gage R&R

SPC programs

PFMEAs

Control Plans

Description du poste

Quality Engineer, Medical Device Manufacturing

Location: Sault Ste. Marie, MI
Job Type: Full-time
Pay: $85,000 to $95,000 per year
Relocation: Lump sum available

Ensure the quality of high-precision surgical products at a growing medical device manufacturer backed by a global industrial organization.

Must-Haves

• Bachelor’s degree in Engineering
• Experience with precision measuring equipment
• Experience working with internal and external customers
• Strong analytical skills and attention to detail

What You’ll Do

• 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

Nice-to-Haves

• 3+ years of quality engineering in manufacturing
• Six Sigma training
• Lean Manufacturing experience
• Medical device or other regulated manufacturing experience

Compensation and Benefits

• $85,000 to $95,000 per year
• BCBS health, dental, and vision insurance
• 401(k) match
• Paid time off
• Relocation lump sum

About the Company

Our client is a growing medical device manufacturer producing high-precision surgical products, backed by a global industrial organization.