Responsibilitiesarrow_right * Communicate department goals and objectives to others, ensuring workload is distributed appropriately to achieve goals and objectives. * Lead Carpinteria Quality Review Board (QRB) and Corrective / Preventative Action (CAPA) * Ensure appropriate actions are taken to resolve quality non-conformances in a timely manner. * Lead quality engineering improvement projects to completion within defined timelines. * Reviews and approves Processes Changes, Quality Plans, Validation Protocols/Reports, TMV's, as necessary. * Support external audits from customer, notify bodies and regulatory agencies. * Support the internal audit program by performing audits (internal, external and supplier) and closure of audit concerns. * Provide support and expertise in the implementation and enforcement of ISO13485, * QSR, and MDSAP requirements, and any other applicable regulations. * Ensure systems and specific product procedures are in place to release product meeting pre-defined requirements. * Ensure team personnel are trained appropriately to support required activities. * Provide leadership and direction on project/product teams as it relates to the quality engineering functions. * Participate and provide quality reporting for management reviews and scorecards, as needed. Qualificationsarrow_right * Bachelors degree in Engineering or Science-related field. * 5+ years of increasing experience providing technical support and leadership in regulated environment. * Knowledge and experience with one or more: ISO 13485, QSR and MDSAP. * Ability to successfully work in timeline-driven environment. * Quality Certifications (ASQ CQE, CQA, CQM, etc.) preferred. * Class I, II, III Medical Device Manufacturing experience in controlled environments and sterilization processes (EO, Irradiation, etc.) preferred. * Experience in coaching and utilizing performance management tools and disciplines. * Experience auditing (internal and external) for all elements of ISO 13485 preferred. * Experience with the successful completion of multiple projects for new product development or improvement initiatives. * Proficient with statistical analysis, quality tool, GD&T, Gage R&R, and CAPA investigation and resolution.