Quality Engineer

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

Benefits offered by this job

Health, Dental and Vision Insurance

401k Match

PTO

Relocation Lump Sum

Job summary

ASHFORD CONNEX, LLC in Sault Ste. Marie, Michigan is seeking a Quality Engineer to support our medical device manufacturing operations and ensure product quality and regulatory compliance.

You will lead quality systems, drive CAPA, PFMEA, SPC, and process validation, collaborating with engineering, suppliers, and customers to sustain high quality and continuous improvement.

Qualifications

• Bachelor’s Degree in Engineering required.
• 3+ years of quality engineering experience in manufacturing.
• Experience with precision measuring equipment and cross-functional teams.

Responsibilities

• Support quality activities across manufacturing operations.
• Develop and maintain inspection plans for new and existing products.
• Lead CAPA and MRB processes.
• Develop PFMEA and Control Plans; conduct process capability analyses.

Skills

Six Sigma

SPC

Lean Manufacturing

PFMEA

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.