Medical Device Quality Engineer — On‑Site, ISO 13485

Perryman Company; Northern (KY); Hybrid; USD 70,000 - 100,000; Full time

Job summary

Perryman Company is seeking a Quality Engineer for contract manufacturing focused on medical devices. The role supports Operations, audits, and quality systems from concept through market introduction, ensuring compliance with the Quality Manual and Design Control.

The ideal candidate will drive continuous improvement through SPC, FMEA, DOE, and process validation, collaborating with product development to ensure manufacturability and compliance. On-site in Houston, PA as part of the team.

Qualifications

• Bachelor's degree in Engineering required.
• 2-5 years’ experience in a quality role within a regulated industry preferred.
• Experience with FDA/ISO 13485 inspections is a plus.
• Must be proficient in data analysis using Excel and statistics (Minitab preferred).
• CQE or equivalent certification preferred.

Responsibilities

• Design and implement testing policies and procedures for product and process quality.
• Support Operations, interact with customers, and support Quality Systems and Process Engineering.
• Lead investigations and CAPA activities; manage audits.
• Develop control plans and risk management documentation.
• Lead and support CAPA, 8D root cause analysis, and change management.

Skills

Quality engineering

Statistical analysis

Design of experiments

FMEA

DOE

Lean Six Sigma

Project management

Communication

Education

Bachelor's degree in Engineering

Tools

Minitab

Microsoft Excel

Job description

Perryman Company is seeking a Quality Engineer for contract manufacturing focused on medical devices. The role supports Operations, audits, and quality systems from concept through market introduction, ensuring compliance with the Quality Manual and Design Control.

The ideal candidate will drive continuous improvement through SPC, FMEA, DOE, and process validation, collaborating with product development to ensure manufacturability and compliance. On-site in Houston, PA as part of the team.