Description

You will own the quality engineering lifecycle for medical device products, ensuring compliance with FDA QSR, ISO 13485, and ISO 14971 standards.

Responsibilities

• Establish and maintain the master validation program, including site, product, and process validations.
• Create, review, and support validation protocols and reports to drive process and reliability improvements.
• Lead failure investigations, root cause analysis, and corrective and preventive actions (CAPA).
• Implement and maintain process controls, including Statistical Process Control (SPC) and risk management files.
• Review product designs for manufacturability, testability, and compliance with quality system requirements.

Required Skills

• Bachelor's degree in engineering or a scientific discipline.
• 5+ years of experience in quality engineering, preferably in medical device or regulated industries.
• Working knowledge of FDA Quality System Regulation, ISO 13485, ISO 14971, ISO 10993, and ISO 11135.
• Familiarity with test methods for design, verification, and validation of medical devices.
• Experience with PPAP and PMEA processes.
• Ability to audit Design History Files and resolve documentation issues.
• Strong skills in statistical methods, root cause analysis, and failure analysis.

Preferred Skills

• Experience with Class II medical devices, pharmaceutical, military, or nuclear industries.
• Knowledge of EU Medical Device Directive.

Key Skills

Education

Bachelor's degree