Quality Engineer, Medical Device Manufacturing

Precision Edge; Sault Ste. Marie, Northern (MI, KY); Hybrid; USD 65,000 - 90,000; Full time

Job summary

Precision Edge, part of Marmon Holdings, is seeking a Quality Engineer in Sault Ste. Marie, MI. The role requires a BS in Engineering and 3+ years in quality engineering. You will create inspection plans, support manufacturing processes, and drive CAPA, PFMEA and Control Plans, with strong emphasis on MSA, DOE and SPC.

You will interface with customers and suppliers, applying ISO 13485/ISO-9001 standards and FDA QSR requirements to ensure product quality and process capability.

Qualifications

• BS in Engineering required.
• 3+ years experience in quality engineering preferred.
• Knowledge of ISO 13485 and/or ISO-9001 Quality Systems.

Responsibilities

• Create inspection plans for new and existing product.
• Provide Quality support through manufacturing process.
• Facilitate Corrective and Preventive Actions (CAPA).
• Develop and maintain PFMEA and Control Plans.
• Conduct Gage R&R studies and improve inspection methods.

Skills

Six Sigma

SPC

Lean Manufacturing

Measurement System Analysis

Design of Experiments

Process Capability Analysis

ISO 13485

FDA QSR 21CFR 820

Education

BS in Engineering

Tools

PFMEA

Control Plans

Gage R&R

DOE

Job description

Precision Edge, part of Marmon Holdings, is seeking a Quality Engineer in Sault Ste. Marie, MI. The role requires a BS in Engineering and 3+ years in quality engineering. You will create inspection plans, support manufacturing processes, and drive CAPA, PFMEA and Control Plans, with strong emphasis on MSA, DOE and SPC.

You will interface with customers and suppliers, applying ISO 13485/ISO-9001 standards and FDA QSR requirements to ensure product quality and process capability.