Quality Engineer - Medical Devices & Process Excellence

Marmon Holdings; Sault Ste. Marie (MI); On-site; USD 75,000 - 105,000; Full time

Job summary

Precision Edge Surgical Products Company LLC, part of Marmon Holdings, seeks a Quality Engineer to uphold stringent manufacturing standards. You will review processes, develop inspection plans, and collaborate with suppliers and customers to ensure compliant, high-quality medical device components.

The role requires BS in engineering, 3+ years quality experience, knowledge of ISO 13485/9001, PFMEA, SPC, and Six Sigma; strong documentation, and ability to lead corrective actions.

Qualifications

• BS in Engineering required.
• 3+ years experience in quality engineering preferred.
• Experience with measuring equipment is required.
• Knowledge of ISO 13485 and ISO-9001 standards.
• Strong documentation and interpersonal skills.

Responsibilities

• Participate in Material Review Board (MRB).
• Participate in New Product Release Review (NPR).
• Create inspection plans for new and existing product.
• Provide Quality support through manufacturing process.
• Facilitate Corrective and Preventive Actions.
• Facilitate Validation activities.
• Create and maintain PFMEA’s and Control Plans.
• Understand and Implement Customer Specific Requirements.
• Facilitate Customer Audits.
• Train employees as needed.

Skills

Six Sigma

SPC

Interpersonal skills

Organizational skills

Analytical skills

Planning

Supervisory

ISO 13485

ISO 9001

FDA QSR 820

Education

BS in Engineering

Job description

Precision Edge Surgical Products Company LLC, part of Marmon Holdings, seeks a Quality Engineer to uphold stringent manufacturing standards. You will review processes, develop inspection plans, and collaborate with suppliers and customers to ensure compliant, high-quality medical device components.

The role requires BS in engineering, 3+ years quality experience, knowledge of ISO 13485/9001, PFMEA, SPC, and Six Sigma; strong documentation, and ability to lead corrective actions.