Senior Quality Assurance Analyst (onsite) || Medical Device at Buffalo, New York, USA |
Email: [email protected] |
From: Akhilesh, DMS VISIONS [email protected] Reply to: [email protected] Hi, Hope you are doing well, Title : Senior Quality Assurance Analyst (onsite) Duration : 6+months Location : Buffalo, NY onsite Visa : open Client domain: Medical Device Manufacturers Relocation will considerable Need extensive background in medical devices, we do not software testers which are the profiles in receiving Job description: Our client, one of the largest Medical Device Manufacturers in the world are seeking an experienced Senior Quality Manager to help lead a team in the day-to-day operations. Role Responsibilities: Lead a team of Engineers on day-to-day operations such as CAPA and NCRs. Provide support for New Product Development launches. Deal with any Risk Management issues that are associated with Regulated Products. Help drive site Quality Metrics such as Complaints, CAPAs, NCRs and Cost of Quality. Provide support for Quality Culture. Support and help make key decisions regarding Quality as you would be the Quality Management Representative. Liaise with suppliers, customers and regulatory bodies when the need arises. Working to ISO, GMP, GDP standards. Role Requirements: Needs to have good knowledge of 13485. Will manager day to day operations CAPAs NCRs etc. Has teams under them these teams could be a mix of inexperience and experienced engineers. Will have a Bachelors degree in engineering, Math or Statistics. Masters degree preferred. ASQ certification preferred. Regulatory Affairs Professional Society (RAPS) medical device certification preferred. At least, 10-12 years of experience in quality or technical functions within the medical device industry, with 3-5 years in managerial experience Experience with Class III & Implantable devices is an advantage Thank you Akhilesh Keywords: New York |
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Thu Nov 09 01:52:00 UTC 2023 |