Quality Engineer - Medical Devices | CAPA, SPC & Lean

Sora Resource Group; Sault Ste. Marie (MI); On-site; USD 85,000 - 100,000; Full time

Benefits offered by this job

Health Insurance

Dental and Vision Insurance

401k Match

PTO

Relocation Lump Sum

Job summary

Sora Resource Group in Michigan is seeking a Quality Engineer to support medical device manufacturing, focusing on quality systems, process improvement, and regulatory compliance.

The role requires a Bachelor’s in Engineering and 3+ years of quality engineering experience, with skills in PFMEA, SPC, CAPA, and supplier quality. The base salary is in the $85-95k range with relocation support.

Qualifications

• Bachelor’s degree in engineering is required.
• 3+ years in quality engineering in manufacturing preferred.
• Experience with internal and external customers.
• Experience using precision measuring equipment.

Responsibilities

• Support quality activities across manufacturing operations.
• Develop and maintain inspection plans for products.
• Participate in MRB and New Product Release Reviews.
• Lead CAPA activities.
• Support validation activities for processes/products.
• Develop PFMEA and Control Plans.
• Conduct process capability and statistical analyses.
• Develop SPC programs and perform Gage R&R/MSA.
• Evaluate inspection methods and quality procedures.
• Program and support inspection equipment.
• Conduct supplier quality activities and audits.
• Support internal and external customer audits.
• Develop and update work instructions and quality docs.
• Train employees on quality procedures.

Skills

Analytical thinking

Attention to detail

Quality systems experience

Education

Bachelor’s Degree in Engineering

Tools

PFMEA

Control Plans

SPC

Gage R&R

MSA

CAPA

Job description

Sora Resource Group in Michigan is seeking a Quality Engineer to support medical device manufacturing, focusing on quality systems, process improvement, and regulatory compliance.

The role requires a Bachelor’s in Engineering and 3+ years of quality engineering experience, with skills in PFMEA, SPC, CAPA, and supplier quality. The base salary is in the $85-95k range with relocation support.