Quality Engineer: Medical Device QC & CAPA Leader

Ashton North LLC; Sault Ste. Marie (MI); On-site; USD 85,000 - 95,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401k match

PTO

Relocation lump sum

Job summary

Ashton North LLC in Sault Ste. Marie, Michigan seeks a Quality Engineer to join a growing medical device manufacturer backed by a global organization. You will support quality systems, CAPA, inspection plans, and process improvements in a highly regulated environment.

The ideal candidate has a Bachelor's in Engineering and 3+ years of quality engineering experience in manufacturing, with strong analytical skills and attention to detail. Base salary range $85-95k plus benefits.

Qualifications

• 3+ years of quality engineering experience in manufacturing environment.
• Experience supporting manufacturing quality systems and regulatory compliance.

Responsibilities

• Support quality activities across manufacturing operations
• Develop and maintain inspection plans for products
• Lead CAPA and MRB activities
• Develop PFMEA and Control Plans
• Conduct process capability and Gage R&R analyses
• Support internal and external audits
• Train employees on quality procedures and inspection standards

Skills

Analytical ability

Attention to detail

Education

Bachelor's Degree in Engineering

Tools

PFMEA

Control Plans

SPC

Job description

Ashton North LLC in Sault Ste. Marie, Michigan seeks a Quality Engineer to join a growing medical device manufacturer backed by a global organization. You will support quality systems, CAPA, inspection plans, and process improvements in a highly regulated environment.

The ideal candidate has a Bachelor's in Engineering and 3+ years of quality engineering experience in manufacturing, with strong analytical skills and attention to detail. Base salary range $85-95k plus benefits.