Principal Quality Engineer
My client is a medical device company dedicated to the treatment of ENT conditions to over 29 million people in the United States. They are looking to add a Principal Quality Engineer to their team to help establish and maintain quality assurance standards that adhere to state, federal, and international regulations. You would be working cross functionally with a wide variety of departments in order to maintain a consistent, top-tier level of quality throughout the entire site.
Job Responsibilities:
- Provides input and compliance review on the following records: Qualification/validation plans, protocols, & reports, Change Controls, Deviations and CAPAs related to facility, utility, equipment, and processes.
- Provides quality and compliance assessments to senior management as required and contributes to strategic direction or initiatives to achieve organizational effectiveness.
- Provides direction and alignment across different functions and influences both strategic and tactical Quality input to develop product quality strategies and life cycle management decisions for both clinical and commercial products in alignment with overall product strategies and is accountable for decisions on product quality.
- Leads investigations in response to quality signals / complaint trends, CAPA or critical deviations
Job Requirements:
- Bachelor's degree in an engineering or science field- Master's degree preferred
- 6+ years of experience in a QA or GMP environment for pharmaceutical products (including combination devices that have a drug component)
- Experience with quality system elements - cGMP strongly preferred
Don't hesitate to apply if you're ready for the next step in your career!
