Job Summary

• The Senior Quality Engineer is responsible for setting detailed guidelines on inspection and testing requirements to ensure products meet company and industry quality standards.
• This role involves collaborating with suppliers to investigate root causes and corrective actions, auditing suppliers, and deploying variation management tools to mitigate risk.
• The position requires maintaining compliance with ISO and FDA regulations and designing methods for process control, improvement, testing, and inspection.

Matching Summary

Skills & Requirements

Key Requirements

• Bachelor’s degree in engineering
• 3-7 years regulated manufacturing experience
• Knowledge of ISO13485, ISO14971, CFR part 820
• ASQ Lead Auditor or equivalent auditing training
• Experience with complaint handling software
• Master’s degree preferred

Work Rights