Quality Engineer

Top Echelon Software; Sault Ste. Marie (MI); On-site; USD 90,000 - 100,000; Full time

Benefits offered by this job

Health, Dental and Vision Insurance (C

401k Match

PTO

Relocation Lump Sum

and much more

Job summary

Top Echelon Software seeks a Quality Engineer for a medical manufacturing environment in Sault Ste. Marie, MI.

The role focuses on ensuring product quality, process capability, and regulatory compliance within a highly regulated manufacturing setting. The successful candidate will develop and maintain quality systems, lead continuous improvement projects, and collaborate with manufacturing, engineering, suppliers, and customers to uphold top quality standards.

Qualifications

• Bachelor's degree in engineering required.
• 3 years of quality engineering experience in manufacturing preferred.
• Experience with multiple types of precision measuring equipment.

Responsibilities

• Support manufacturing operations with quality activities.
• Develop inspection plans for new and existing products.
• Lead CAPA and MRB activities.
• Develop PFMEA and Control Plans.
• Support process validation and product validation activities.
• Perform process capability studies and SPC analyses.
• Develop and maintain SPC programs and measurement systems.
• Conduct Gage R&R and Measurement System Analysis.
• 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

Six Sigma methodologies

Statistical Process Control (SPC)

Lean Manufacturing

PFMEA and Control Plans

Education

Bachelor's Degree in Engineering

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 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
• 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.