Quality Engineer

Aspire Talent Solutions; Sault Ste. Marie (MI); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Competitive compensation

Health, Vision and Dental Insurance

401k Match

PTO and Holidays

Job summary

Aspiring medical instrument manufacturer in Sault Ste. Marie, MI seeks two Quality Engineers to join its local plant and drive quality improvement initiatives.

The role focuses on developing and maintaining quality systems, CAPA leadership, PFMEA, SPC, and process validation to ensure top product quality for orthopedic surgical instruments.

Qualifications

• Bachelor's Degree in Engineering required.
• 3+ years of quality engineering in manufacturing.
• Experience with internal and external customers.
• Experience using 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
• Support process and product validation
• Develop PFMEA and Control Plans
• Conduct process capability and statistical analysis
• Develop and maintain SPC programs
• Perform Gage R&R and MSA
• 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 quality documentation
• Train employees on quality procedures

Skills

Six Sigma

Statistical Process Control

Lean Manufacturing

PFMEA

Control Plans

Gage R&R

Measurement System Analysis

CAPA

Process Capability

Root Cause Analysis

Education

Bachelor's Degree in Engineering

Tools

CMM

Calipers / Gauges

Gage blocks

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
• Statistical Process Control (SPC)
• Lean Manufacturing
• 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