Quality Engineer – Medical Devices | CAPA & SPC

True North Consultants; Sault Ste. Marie (MI); On-site; USD 90,000 - 100,000; Full time

Benefits offered by this job

Health, Dental and Vision Insurance (M

401k Match

PTO

Relocation Lump Sum

and much more

Job summary

True North Consultants in Sault Ste Marie, MI is seeking a Quality Engineer to join a growing medical device team. You will support manufacturing operations, develop inspection plans, and drive CAPA, MRB, and NPI reviews to uphold product quality in a regulated environment.

The role focuses on process capability, quality documentation, supplier audits, and collaboration with internal teams to ensure compliance and continuous improvement in surgical product manufacturing.

Qualifications

• Bachelor's degree in Engineering required.
• 3 years of quality engineering experience in a manufacturing environment preferred.
• Experience supporting manufacturing quality systems and regulatory compliance.

Responsibilities

• Support quality activities across manufacturing operations.
• Develop and maintain inspection plans for new and existing products.
• Lead CAPA and support MRB and New Product Release Reviews.
• Develop and maintain PFMEA and Control Plans.
• Conduct process capability and SPC analyses.
• Program and support inspection equipment and gage R&R.
• Conduct vendor audits and supplier quality activities.
• Support internal and external customer audits.
• Train employees on quality procedures and inspection standards.

Skills

Analytical skills

Attention to detail

Quality systems experience

Communication skills

Education

Bachelor's Degree in Engineering

Job description

True North Consultants in Sault Ste Marie, MI is seeking a Quality Engineer to join a growing medical device team. You will support manufacturing operations, develop inspection plans, and drive CAPA, MRB, and NPI reviews to uphold product quality in a regulated environment.

The role focuses on process capability, quality documentation, supplier audits, and collaboration with internal teams to ensure compliance and continuous improvement in surgical product manufacturing.