Quality Engineer

Keystone Distinction Group; Michigan; On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Competitive Compensation

Health, Vision and Dental Insurance

401k Match

PTO and Holidays Plan

Job summary

Keystone Distinction Group, located in Sault Ste. Marie, MI, is hiring two Quality Engineers to enhance manufacturing operations. This role involves developing quality systems, ensuring regulatory compliance, and driving process improvements.

Ideal candidates will have a Bachelor’s Degree in Engineering and at least 3 years of quality engineering experience in manufacturing. Competitive compensation and comprehensive benefits are offered, contributing to a growing company impacting the surgical instrument industry.

Qualifications

• Minimum of 3 years of experience in quality engineering in a manufacturing environment.
• Proven experience working with internal and external customers.
• Knowledgeable in Six Sigma methodologies and Lean Manufacturing.

Responsibilities

• Support quality activities across manufacturing operations.
• Develop and maintain inspection plans for new and existing products.
• Lead corrective and preventive actions (CAPA).
• Conduct vendor audits and supplier quality activities.

Skills

Quality engineering

Process improvement

Statistical Process Control (SPC)

Six Sigma methodologies

Lean Manufacturing

Education

Bachelor’s Degree in Engineering

Tools

Precision measuring equipment

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

• 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 instruments