Quality Engineer – Medical Devices | CAPA, SPC & PFMEA

Eden Capital Careers; Sault Ste. Marie (MI); On-site; USD 90,000 - 100,000; Full time

Benefits offered by this job

Health insurance

401k Match

PTO

Relocation Lump Sum

Job summary

Eden Capital Careers seeks a Quality Engineer in Michigan for a growing medical device manufacturer. The role focuses on supporting quality systems, process improvements, and regulatory compliance in a highly controlled manufacturing environment.

You will collaborate with manufacturing, engineering, suppliers and customers to maintain high product quality and drive continuous improvement, including CAPA, PFMEA, and SPC activities.

Qualifications

• Bachelor’s Degree in Engineering required.
• 3+ years of experience in quality engineering within a manufacturing environment.
• 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.
• Lead CAPA and participate in MRB and New Product Release Reviews.
• Develop and maintain PFMEA and Control Plans.
• Conduct process capability and statistical analysis.

Skills

Quality engineering

Process improvement

CAPA

Education

Bachelor’s degree in Engineering

Tools

Gage R&R

SPC

PFMEA

Measurement equipment

Job description

Eden Capital Careers seeks a Quality Engineer in Michigan for a growing medical device manufacturer. The role focuses on supporting quality systems, process improvements, and regulatory compliance in a highly controlled manufacturing environment.

You will collaborate with manufacturing, engineering, suppliers and customers to maintain high product quality and drive continuous improvement, including CAPA, PFMEA, and SPC activities.