What are the responsibilities and job description for the Quality Engineer position at Katalyst Healthcares & Life Sciences?
Company Description
- Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
- We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.
Job Description
Roles & Responsibilities:
- Quality Engineer withs strong medical device experience and PRODUCT QUALITY. MUST have experience with Class III/Implantable medical device(s).
- Experience maintaining/working within an ISO 13485 Quality Management System (QMS)
- Experience with CAPA Process.
- CE Marking experience.
- Good team player works cross functionally with Engineering and Quality.
- Solid understanding of regulatory standards & requirements (13485, MDR and FDA).
- Experience managing Quality Management System documents and systems.
Additional Information
All your information will be kept confidential according to EEO guidelines.
