Sr. Quality Assurance & Regulatory Affairs Manager

About the JobThe Regulatory Affairs and Quality Assurance Manager will provide Quality Management, Regulatory and Quality Engineering expertise, direction and hands-on involvement regarding quality processes, biomedical regulatory affairs, and systems to drive continuous improvement in support of quality and compliance objectives. This position reports to the Global RA/QA Director.This is a full-time, exempt position based in Everett, WA. Fluke Health Solutions offers competitive salary, time off, and benefits. Our offering includes PTO, paid holidays, medical/dental/vision on Day 1 + many more. Bring your whole self to FHS!ResponsibilitiesLeads and participates in formal problem-solving processes, conducts root cause and corrective action investigations for quality failures, including those occurring in supplier, in-house processes and Client-side findings.Supports the Director, RAQA for all Quality and Regulatory strategy plans, actions, implementation and upskilling as the Business grows.Leads overall site compliance efforts, including, but not limited to:Support for regulatory meetings with FDA.External health authority inspections and audit readiness and logistics.Front room audit host, RA/QA Subject Matter Authority, and/or backroom support.Key liaison for agency communications as the need arises.Lead follow-up activities for post-inspection root cause and correction action plan for identified corrections.Completion of essential functions includes the effective application of: Gage R&R Studies, Design of Experiments, Failure Mode and Effects Analysis, Statistical Process Control, the determination of Operating Characteristics for Sampling Plans, and statistical analysis to effect quantifiable product and process improvements.Fulfills QA/RA subject matter authority role for all functional areas.Maintains Risk Management conformance to 14971 requirements, including governance of risk tools such as FMEA, Hazard Analysis, Risk-Benefit, etc.Drives effective and efficient improvement of inspection and test methods, sampling plans, and process control plans.Prepares and conducts training sessions and presentations in support of quality objectives.Actively participates in new product development teams and sustaining design change activities and fulfills RA/QA required actions.Lead the site CAPA system and ensure effective CAPA Review Board.Lead all aspects of the Complaint system for timely complaint handling and MDR reporting ability.Maintains applicable licenses and registrations to support global market.RA/QA review for customer-facing marketing materials per FHS processes.Supports all facets of the internal audit system including scheduling, auditing, reporting, and corrective actions.Supports all facets of the supplier qualification and audit system including scheduling, auditing, reporting, and corrective actions with follow-ups.Maintains a professional working relationship with internal and external customers and support staff.Provide metrics to Leadership for overall compliance initiatives and report on health of the QMS.Actively lead, support, mentor and develop RA/QA team members and others as needed.Provide resource assignments across team members to support all cross-functional business activities.QualificationsBachelor’s degree (B.S. or equivalent experience) in engineering or science field from a four-year college or university.Consistent track record to lead, grow in a Leadership position, and enable Team members to grow as well.Minimum of seven years’ experience in Quality Assurance and three years’ experience in Regulatory Affairs in an FDA regulated industry.Four years’ people management experience. Track record of building and leading high-performance teams.Working knowledge of Quality Management Systems – 21 CFR Part 820, ISO 9001/13485, ISO 14971, ISO 17025 in development and manufacturing environments.Marked ability to learn new applicable standards, resolve how they apply to the Business and provide related guidance cross-functionally.Strong interpersonal skills with the ability to be a standout colleague and Leader; setting a professional tone and establishing a collaborative partnership within the department and other areas of the Company to optimally resolve problems.Ability to interpret trends and data, translating the information into actions, outcomes, and improvements.Excellent documentation skills, with a proven process orientation and effective attention to detail.

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