Quality Engineer, Medical Devices: Process Improvement & CAPA

Markent Personnel; Sault Ste. Marie (MI); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health, Vision and Dental Insurance

401k Match

PTO and Holidays Plan

Competitive Compensation

Job summary

Markent Personnel is seeking two Quality Engineers for a medical instrument manufacturing plant in Sault Ste Marie, MI. The role will support manufacturing operations by developing and maintaining quality systems, leading process improvements, and ensuring regulatory compliance.

You will work with manufacturing, engineering, suppliers, and customers to sustain high product quality and drive continuous improvement. Bachelor's in Engineering and 3+ years' experience required.

Qualifications

• Bachelor’s degree in engineering is required.
• 3+ years of quality engineering experience 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 (Corrective and Preventive Actions).
• Support and facilitate process and product validation activities.
• Develop 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 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.

Job description

Markent Personnel is seeking two Quality Engineers for a medical instrument manufacturing plant in Sault Ste Marie, MI. The role will support manufacturing operations by developing and maintaining quality systems, leading process improvements, and ensuring regulatory compliance.

You will work with manufacturing, engineering, suppliers, and customers to sustain high product quality and drive continuous improvement. Bachelor's in Engineering and 3+ years' experience required.