Quality Engineer

RNInk; Sault Ste. Marie (MI); On-site; USD 70,000 - 100,000; Full time

Job summary

RNInk is seeking a Quality Engineer to join its growing medical device manufacturing team in Michigan. The role focuses on developing and maintaining quality systems, driving CAPA, and ensuring regulatory compliance in a highly controlled environment.

Ideal candidates have 3+ years of quality engineering experience in manufacturing, with hands-on use of precision measuring equipment and strong analytical skills.

Qualifications

• Bachelor's degree in Engineering is required.
• 3+ years of experience in quality engineering within a manufacturing environment preferred.
• Experience working with internal and external customers and with 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

CAPA

SPC

Gage R&R

Measurement System Analysis

Statistical analysis

Process improvement

Education

Bachelor’s Degree in Engineering

Tools

Precision measuring equipment

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.