Leads 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 plans, actions, implementation, and upskilling as the Business grows.
Leads overall site compliance efforts. Regulations in scope: FDA applicable to class I and class II medical devices including 510k clearances. Prepare documentation for regulatory meetings with the FDA.
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.