Quality Management System
Our client has a quality assurance & regulatory compliance manager position in mahwah, new jersey description: the manager, quality assurance & regulatory compliance will ensure overall quality management system (qms) compliance with applicable regulatory and statutory requirements. The successful candidate will manage the manufacturing site’s internal and external audit functions and will coordinate activities of third party audits /visits. In addition, the manager, quality assurance & regulatory compliance will be responsible for leading and managing a group of quality professionals to ensure a high level of quality management system and regulatory compliance in the plant. This position will be responsible for quality management system improvement, procedure development, and qms implementation. The manager will coordinate management review, capa, ncrb, complaints, product field actions, and related document control functions. Detailed responsibilities of the manager, quality assurance & regulatory compliance include, but are not limited to the following: *ensure overall qms system compliance with applicable regulatory and statutory requirements. *perform internal quality assurance audits to 21cfr 820, iso 9001:2000, iso 13485:2003, 93/42/eec and other applicable standards to ensure corporate and regulatory compliance *develop and conduct effective training programs on related qa topics. *conduct and support benchmarking activities. *identify areas of opportunity and support continual improvement of the quality management system identify, develop, and report qms metrics. *manage internal audits, capa system, complaint handling (investigation/resolution), document control. Requirements: a bachelor's degree in a scientific or other relevant field is required. A master's degree or equivalent additional coursework is desirable. Internal or lead auditor certification (cqa) is preferred. A minimum of 5 years of experience managing a team is also required. 3 years of experience in a quality role in the medical device industry is also desired. Ideal candidates should also possess the following skills/experiences: applied understanding of cgmps, iso 9001, iso 13485, and fda qsr. *demonstrated ability to effectively lead cross-functional/cross-plant project teams using relevant project management tools such as ms project. *demonstrated experience developing quality management systems, designing and developing training programs/courses. Experience with lean and six sigma methodology and tools. *demonstrated auditing experience in medical device or other regulated manufacturing environment (biotech, pharma, military, aerospace, automotive).
Please consider AlvaMed if your client requires contract support in the short-term before they are a...1.4 Days Later
This sounds interesting. It's a pitty that I can't meet up in person for a chat, since I am seeking ...2 Days Later
Andrea |Principal Consultant
Hello, I have 18 years of experience in medical device Quality Systems and *****irs. Wou...3.5 Days Later