Quality Engineer

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

Benefits offered by this job

Health, Dental and Vision Insurance (H

401k Match

PTO

Job summary

Calqulate Metrics Ltd in Sault Ste. Marie, Michigan, seeks a Quality Engineer to support a high‑precision medical device manufacturing environment, maintaining quality systems and driving CAPA, PFMEA, and SPC to ensure regulatory compliance.

The ideal candidate has a Bachelor’s in Engineering and 3+ years of experience with precision measuring equipment, plus strong collaboration with suppliers and customers to enable continuous improvement.

Qualifications

• Bachelor’s degree in engineering required.
• 3+ years in quality engineering within a manufacturing environment.
• Experience with internal and external customers.
• 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.
• Participate in MRB and New Product Release Reviews.
• Lead CAPA activities.
• Develop and maintain PFMEA and Control Plans.
• Conduct process capability and statistical analysis.
• Develop and maintain 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.

Skills

Quality engineering

Process improvement

Lean manufacturing

Statistical analysis

CAPA

Regulatory compliance

Education

Bachelor’s degree in Engineering

Tools

Measuring equipment

Gage R&R

Job description

Quality Engineer

Medical Manufacturing

Sault Ste Marie, Michigan

$90-100k

A growing medical device manufacturer backed by a global industrial organization and is seeking a Quality Engineer to join its team. The company produces high-precision surgical products within a highly regulated manufacturing environment.

This role plays a critical part in ensuring product quality, process capability, and compliance with industry standards. The ideal candidate will have strong analytical abilities, attention to detail, and experience supporting manufacturing quality systems.

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 activitiesDevelop 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
• Statistical Process Control (SPC)
• Lean Manufacturing
• PFMEA and Control Plans

Benefits

• Base: $85-95k
• Health, Dental and Vision Insurance (BCBS)
• 401k Match
• PTO
• Relocation Lump Sum
• and much more

This is a great opportunity with a great company.