Quality Engineer

H. T. PROF Group; Michigan; Hybrid; USD 68,000 - 90,000; Full time

Benefits offered by this job

Competitive Compensation

Health, Vision and Dental Insurance

401k Match

PTO and Holidays

Job summary

H. T. PROF Group seeks a Quality Engineer for its Sault Ste. Marie, MI plant to bolster quality systems and drive continuous improvement in orthopedic surgical instrument production.

The role collaborates with manufacturing, engineering, suppliers, and customers to ensure high product quality, lead CAPA investigations, and support validation activities across processes and products.

Qualifications

• Bachelor's degree in engineering is required.
• 3+ years of experience in quality engineering in a manufacturing environment preferred.
• Experience working 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 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 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

CAPA

SPC

Gage R&R

Process validation

Inspection methods

Education

Bachelor's Degree in Engineering

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:

• PFMEA and Control Plans

• 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