Contract position: Sustaining Quality Engineer needed for an amazing opportunity in the Exton, PA area. The Sustaining Quality Engineer is responsible providing technical quality leadership and support for the company's on-market medical device and combination products. Apply now for immediate consideration!Responsibilities for the Quality Engineer
Requirements for the Quality Engineer
- Support transition of product licenses between Shire locations and implementation of new MDR/IVDR regulations
- Perform batch record review for Contract Manufacturing Organization (CMO) manufactured medical devices globally
- Support global evaluation and coordination of complaint investigation activities for devices and combination products
- Support deviations, CAPAs, internal / external inspections, training and notified body interactions related to transition and new regulations
- Perform and support supplier quality related activities for devices and combination products
- BS and/or MS in engineering or equivalent technical discipline required, and advanced degree preferred
- 6+ years of device and/or combination product quality engineering experience within a medical device or biopharmaceutical organization required
- Extensive knowledge of both US and International medical device quality system requirements (ISO 13485, ISO 14971)
- Experience in providing quality support to on-market/commercialized products required.
- Experience with statistical and six sigma methods required, and Green/Black Belt preferred
- Industry leading contractor benefits available! Apply now!
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.