Quality Engineer – Medical Devices & Process Improvement

True North Consultants, Inc.; Sault Ste. Marie (MI); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Health, Vision and Dental Insurance

401k Match

PTO and Holidays Plan

Competitive Compensation

Job summary

True North Consultants, Inc. in Michigan is seeking two Quality Engineers for our local plant to support the manufacturing of orthopedic surgical instruments. You will develop and maintain quality systems, lead process improvements, and ensure regulatory compliance.

Join a growing team focusing on inspection plans, CAPA, PFMEA, SPC, Gage R&R, and supplier audits while collaborating with suppliers and customers to drive continuous improvement.

Qualifications

• Bachelor’s Degree in Engineering required.
• 3+ years of experience in quality engineering within a manufacturing environment preferred.
• Experience using multiple types of precision measuring equipment.
• Experience working with internal and external customers.
• Lean, Six Sigma, PFMEA and Control Plans experience preferred.

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 CAPA initiatives and drive corrective actions.
• Support process and product validation activities.
• Develop PFMEA and Control Plans.
• Conduct process capability and statistical analysis.
• Develop SPC programs and perform Gage R&R.
• Collaborate with suppliers and customers to standardize inspection processes.

Skills

Quality engineering

CAPA

Process improvement

Statistical analysis

Education

Bachelor’s Degree in Engineering

Tools

PFMEA

Control Plans

SPC

Gage R&R

Job description

True North Consultants, Inc. in Michigan is seeking two Quality Engineers for our local plant to support the manufacturing of orthopedic surgical instruments. You will develop and maintain quality systems, lead process improvements, and ensure regulatory compliance.

Join a growing team focusing on inspection plans, CAPA, PFMEA, SPC, Gage R&R, and supplier audits while collaborating with suppliers and customers to drive continuous improvement.