Quality Engineer - Medical Devices (CAPA, SPC, PFMEA)

Your Talent Team; Sault Ste. Marie (MI); On-site; USD 90,000 - 100,000; Full time

Benefits offered by this job

Health, Dental & Vision Insurance

401k Match

PTO

Relocation Lump Sum

Job summary

Your Talent Team is seeking a Quality Engineer for a growing medical device manufacturer in Sault Ste. Marie, Michigan. You will support manufacturing operations, develop and maintain quality systems, and drive continuous improvement in a highly regulated environment.

The role requires a Bachelor’s in Engineering and 3+ years of experience, with PFMEA/Control Plans, SPC, Six Sigma, and strong analytical skills. Base salary range includes relocation support and benefits.

Qualifications

• Bachelor’s Degree in Engineering required.
• 3+ years of quality engineering in a manufacturing environment.
• Experience working with internal and external customers.
• Experience using multiple types of precision measuring equipment.

Responsibilities

• Support quality activities across manufacturing operations.
• Develop and maintain inspection plans for new and existing products.
• Participate in MRB and New Product Release Reviews.
• Lead corrective and preventive actions (CAPA).
• Support and facilitate process and product validation activities.
• Develop PFMEA and Control Plans.
• Conduct process capability and statistical analysis.
• Develop SPC programs.
• Perform Gage R&R and Measurement System Analysis.
• Evaluate and improve inspection methods and quality procedures.
• Program and support inspection equipment.
• Conduct vendor audits and supplier quality activities.
• Support internal and external customer audits.
• Develop and update work instructions and quality documentation.
• Train employees on quality procedures and inspection standards.
• Collaborate with suppliers and customers to standardize inspection processes.

Skills

Analytical thinking

Attention to detail

Experience supporting manufacturing QC

Communication with customers

Education

Bachelor’s Degree in Engineering

Tools

PFMEA

Control Plans

SPC

Gage R&R

Job description

Your Talent Team is seeking a Quality Engineer for a growing medical device manufacturer in Sault Ste. Marie, Michigan. You will support manufacturing operations, develop and maintain quality systems, and drive continuous improvement in a highly regulated environment.

The role requires a Bachelor’s in Engineering and 3+ years of experience, with PFMEA/Control Plans, SPC, Six Sigma, and strong analytical skills. Base salary range includes relocation support and benefits.