Quality Assurance Manager
Develop, integrate and maintain the quality management system (QMS) supporting both soft and hard goods. Manage quality assurance process at all contract manufacturing partners including testing standards and reporting. Lead interactions with the CPSC, FDA, JPMA and other key agencies in safety and quality related matters. Partner in R&D process to ensure products meet safety and regulatory standards while also meeting business objectives and timelines. Oversee delivery of required documentation for Retail and Hospital Business partners as it relates to quality, engineering, specification and regulatory requirements. Audit contract manufacturing facilities as required. Assure design documentation and traceability of all design changes are in place. Manage external lab partners for cost effective and timely execution. Review and recommend cost containment and continuous improvement opportunities. Work with management and sales to adapt voice of the consumer into design modifications. Ensure that validation and qualification activities are consistent with company validation policies and procedures and federal regulations. Ensure global quality and regulatory standards are in place, documented, and continuously updated. This includes North America, Europe and Asia. Overseeing and managing quality and complaint systems with contract manufacturing partners on commercial products with our end-user customers. Provide Quality support for NCMR, Complaints, internal and external audit findings and CAPAs.
YOUR RECIPE FOR SUCCESS
Strong Interpersonal Skills Ability to work with Cross Functional Teams including Operations, Sales, and Executive Leadership Strong Presentation Skills Strong Verbal Communication Strong Problem-Solving Skills Ability to travel up to 20% of the time
Required10 years or more experience in medical devices. 7+ years’ experience in operations, quality management, compliance, regulatory, or combination of these are required. Working knowledge of FDA regulatory requirements for Class II Medical Devices. Working knowledge of hospital capital equipment. Working knowledge of requirements for CE marks and global registrations. Experience applying quality regulations and standards (e.g. 21CFR 820, ISO 13485, and ISO 14971) and working knowledge of current and applicable GMP regulations is required. Experience writing master validation plans & writing procedures. Experience with process Monitoring Validations, Risk Management, Sampling Plans, Statistics.
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