Quality Engineer — Medical Devices & Process Excellence

Precision Edge Surgical Products Company LLC; Sault Ste. Marie (MI); On-site; USD 70,000 - 90,000; Full time

Job summary

Precision Edge Surgical Products Company LLC in Michigan seeks a Quality Engineer to uphold product quality across manufacturing processes and to support customers and suppliers with clear documentation. You will create inspection plans and provide quality support through manufacturing.

Qualifications include a BS in Engineering and 3+ years in quality engineering. Proficiency with PFMEA, Control Plans, Gage R&R, SPC, Lean Manufacturing, and validation activities is required.

Qualifications

• BS in Engineering required.
• 3+ years experience in quality engineering preferred.
• Experience with PFMEA, Control Plans, Gage R&R, and SPC is preferred.

Responsibilities

• Participate in Material Review Board (MRB).
• Participate in New Product Release Review (NPR).
• Create inspection plans for new and existing products.
• Provide Quality support through manufacturing processes.
• Facilitate Corrective and Preventive Actions.
• Facilitate Validation activities.
• Create and maintain PFMEA and Control Plans.
• Implement and monitor Customer Specific Requirements.
• Facilitate Customer Audits.
• Program inspection equipment and write/update work instructions.
• Use statistical tools to analyze data and improve process capability.
• Develop and maintain a Statistical Process Control program.
• Conduct vendor quality activities.

Skills

Six Sigma

SPC

PFMEA

Control Plans

Gage R&R

DOE / Design of Experiments

Lean Manufacturing

Validation activities

Interpersonal skills

Education

BS in Engineering

Job description

Precision Edge Surgical Products Company LLC in Michigan seeks a Quality Engineer to uphold product quality across manufacturing processes and to support customers and suppliers with clear documentation. You will create inspection plans and provide quality support through manufacturing.

Qualifications include a BS in Engineering and 3+ years in quality engineering. Proficiency with PFMEA, Control Plans, Gage R&R, SPC, Lean Manufacturing, and validation activities is required.