Quality Engineer

H.T. Prof Executive Search; Michigan; On-site; USD 80,000 - 110,000; Full time

Job summary

The Quality Engineer will join a growing medical device manufacturer backed by a global organization. This role supports manufacturing operations by developing and maintaining quality systems, driving continuous improvement, and ensuring compliance with regulatory standards.

The ideal candidate has 3+ years in quality engineering, experience with MRB, CAPA, PFMEA, SPC, and a strong ability to analyze processes and collaborate with suppliers and customers to maintain high product quality.

Qualifications

• Bachelor’s degree in engineering required.
• 3+ years of manufacturing quality engineering experience.
• Experience with CAPA, MRB, and change control processes.
• Experience using precision measuring equipment.
• Ability to develop PFMEA and control plans.
• Strong collaboration with suppliers and customers.

Responsibilities

• Support quality activities across manufacturing operations
• Develop and maintain inspection plans for products
• Lead CAPA and MRB processes
• Support process and product validation activities
• Develop PFMEA and control plans
• Conduct process capability and statistical analysis
• Develop SPC programs and perform Gage R&R
• Conduct vendor audits and supplier quality activities
• Train employees on quality procedures

Skills

Process improvement

CAPA

Statistical analysis

Quality systems

Gage R&R

Cross-functional collaboration

Education

Bachelor's degree in engineering

Tools

PFMEA

Control Plans

SPC

Gage R&R

Job description

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:

• PFMEA and Control Plans
• Health, Dental and Vision Insurance (BCBS)
• and much more

This is a great opportunity with a great company.