Quality Engineer

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

A medical instrument manufacturing company in Sault Ste Marie, MI is looking to hire two Quality Engineers for their local plant.
The company is growing and makes orthopedic surgical instruments for the medical industry. (Think surgical instruments that are hand or robot held and cut muscle, drill through bone, etc.)

Position Overview

The Quality Engineer will support manufacturing operations by developing and maintaining quality systems, leading process improvement initiatives, and ensuring compliance with regulatory standards. This individual will work closely with manufacturing, engineering, suppliers, and customers to maintain high product quality and drive continuous improvement.

Key Responsibilities

• Support quality activities across manufacturing operations
• Develop and maintain inspection plans for new and existing products
• Participate in Material Review Board (MRB) and New Product Release Reviews
• Lead corrective and preventive actions (CAPA)
• Support and facilitate process and product validation activities
• Develop and maintain PFMEA and Control Plans
• Conduct process capability and statistical analysis
• Develop and maintain Statistical Process Control (SPC) programs
• Perform Gage R&R and Measurement System Analysis
• Evaluate and improve inspection methods and quality procedures
• Program and support inspection equipment
• Conduct vendor audits and supplier quality activities
• Support internal and external customer audits
• Develop and update work instructions and quality documentation
• Train employees on quality procedures and inspection standards
• Collaborate with suppliers and customers to standardize inspection processes

Qualifications

Education

• Bachelor’s Degree in Engineering required

Experience

• 3+ years of experience in quality engineering within a manufacturing environment preferred
• Experience working with internal and external customers
• Experience using multiple types of precision measuring equipment

Technical Knowledge

• Preferred experience with: Six Sigma methodologies
• Preferred experience with: Statistical Process Control (SPC)
• Preferred experience with: Lean Manufacturing
• Preferred experience with: PFMEA and Control Plans

Benefits

• Competitive Compensation
• Health, Vision and Dental Insurance
• 401k Match
• PTO and Holidays Plan
• Opportunity to join a growing company impacting thousands around the world by providing needed surgical instuments