Quality Engineer - Medical Devices & Process Excellence

Precision Edge Surgical Products Company LLC; Sault Ste. Marie (MI); On-site; USD 75,000 - 95,000; Full time

Job summary

Precision Edge Surgical Products Company LLC is seeking a Quality Engineer to ensure product quality and process capability in our Michigan facility. The role requires hands-on experience with measurement equipment, PFMEA, Control Plans, and supporting validations across manufacturing lines.

The ideal candidate has a BS in Engineering and 3+ years in quality engineering, with knowledge of Lean, SPC, Gage R&R, and ISO 13485/QSR 21 CFR Part 820.

Qualifications

• BS in Engineering required.
• 3+ years experience in quality engineering preferred.
• 6 Sigma, SPC preferred.
• Understand PFMEA’s and Control Plans.
• Working knowledge of Validation activities.
• Design and Analysis of Experiments.
• Knowledge of Lean Manufacturing.
• Knowledge of Measurement System Analysis (Gage R&R).
• Process and Performance Capability Analysis.
• Must possess excellent interpersonal skills, having the ability to interface with all levels of the organization, customers and suppliers.
• Knowledge of ISO 13485 and/or ISO-9001 International Quality System Standards.
• Knowledge of the FDA’s QSR 21CFR part 820 Medical Device Standard.

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 Preventative Actions.
• Facilitate Validation activities.
• Create and maintain PFMEA’s and Control Plans.
• Understand and Implement Customer Specific Requirements.
• Facilitate Customer Audits.
• Program inspection equipment.
• Write/Update Work Instructions.
• Use statistical tools to analyze data, make recommendations and improve process capability.
• Develop, implement and maintain a Statistical Process Control program.
• Perform special projects and assignments as defined by the Quality Manager.
• Evaluate and improve inspection systems/procedures. Design and implement new inspection methods and improve current inspection methodology.
• Work with customers and suppliers to standardize inspection methods.
• Perform process capability analysis and recommend improvements.
• Perform Gage R&R studies and recommend improvements.
• Perform Vendor Audits.
• Supplier Quality.
• Train employees as needed

Skills

6 Sigma

SPC

PFMEA

Control Plans

Validation

DOE

Lean Manufacturing

Measurement System Analysis (Gage R&R)

Process Capability Analysis

Interpersonal Skills

Education

BS in Engineering

Job description

Precision Edge Surgical Products Company LLC is seeking a Quality Engineer to ensure product quality and process capability in our Michigan facility. The role requires hands-on experience with measurement equipment, PFMEA, Control Plans, and supporting validations across manufacturing lines.

The ideal candidate has a BS in Engineering and 3+ years in quality engineering, with knowledge of Lean, SPC, Gage R&R, and ISO 13485/QSR 21 CFR Part 820.