A leader in developing and providing healthcare in the areas of behavioral health, gastrointestinal conditions, rare diseases, and regenerative medicine is looking for a Post-Market Quality Engineer in the Exton, PA area. This is a 1-year CONTRACT position. No per diem is available.
Responsibilities for the Quality Engineer
- Work collaboratively with internal Quality and cross-functional colleagues to ensure medical devices and combination products comply with FDA 21 CFR requirements and international standards (e.g., ISO, AAMI, ANSI).
- Transition ISO 13485 certification and product licenses between locations / entities due to pending closure of facility. Establishment of harmonized processes to meet new ISO 13485 and MDR requirements expected to be implemented in 2018.
- Internal / external inspections and notified body interactions related to transition and new regulations. Supplier quality related activities during transition of responsibilities from SQM to Device Quality.
Requirements for the Quality Engineer
- 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 (specifically 21 CFR Part 820, Part 803, ISO 13485, ISO 14971), as well as other applicable standards required. Experience in providing quality support to on-market/commercialized products required
- Experience in working with external suppliers &/or contract manufacturers required. Experience in leading quality projects/activities required, and specific experience in leading remediation projects preferred. Experience with risk management processes and tools required.
- Experience with statistical and six sigma methods required, and Green/Black Belt preferred. Experience with drug delivery injection systems preferred.
Benefits for the Quality Engineer