Contract position: Leading medical device company is seeking a Sr. Quality Assurance Engineer for a long term opportunity. Qualified candidates will have a Bachelor's Degree in Engineering or similar discipline and 7-10 years of experience in an FDA regulated industry and at least five years of experience in the medical device industry. This position will support quality control related to the new regulations and requirements that Europe has put forth on medical device regulations. Additional responsibilities and requirements below. Responsibilities for the Senior Quality Engineer
Requirements for the Senior Quality Engineer
- Performs gap assessments between Quality System procedures and EU Medical Device Regulation
- Develops quality plans for Quality System updates to changing regulations and standards.
- Develops and implements procedures, forms and/or templates to assure compliance with Quality System Regulation, EU Medical Device Regulation and ISO 13485:2016 as well as other International regulatory requirements.
- Initiate and complete Quality System change orders in Agile.
- Bachelor's degree in Engineering or related field
- 7-10 years of experience in FDA regulated environment, 5 years of medical device experience
- Must have experience with quality plans and internal audits
- Experience with EU Medical Device Regulation a plus or any type of international regulatory experience
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.