Sr. Manager QA & Regulatory Compliance - #1581

Location: Northern CA

Work with cross-functional teams by providing quality engineering support and leadership for quality related functions for all aspects related to manufacturing, new product development and sustaining engineering. Responsible for assessing compliance with the corporate quality system that includes compliance with applicable international standards and regulations (i.e., ISO 13485, MDD and QSR); and making necessary changes to maintain a high level of compliance with applicable standards and regulation.  Perform internal audits and other duties as assigned. Participate in new product development and sustaining engineering projects as needed.Identify improvement opportunities, recommend improvements and implement changes to quality system including inspection and testing methodologies SKILLS:  Previous experience in Quality System administration and maintenance in the medical device industry. Hands-on experience in Medical Device product quality assurance and quality engineering functions. Knowledge of sterilization methods and validations, biocompatibility. Thorough knowledge of QSR, ISO 13485 (2003), MDD requirements applicable to Class II and Class III product environment. Minimum of 7 years related experience. Project management experience. Bachelor’s degree in Engineering or equivalent experience. ASQ certification (CQE, CQA) 

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