Quality Control Supervisor (JTK)

Quality Assurence SupervisorSomersworth, New HampshireBase salary +/- $140k with bonus and exceptional benefitsThe Quality Supervisor is responsible to supervise and support quality assurance and quality manufacturing functions for all elements of Quality Management System (QMS). This includes: document control, inspection and test, sterilization, process validation, customer support, CAPA, NCR Process & MRB function; customer complaints, review of DHRs, internal audit process, supporting external audits including FDA, Customer, and ISO Notified Body, calibration process, quality metrics, quality records and trend analysis.Quality Supervisor will also provide supervision of the Quality Inspectors, and assure effective coverage of Inspectors to support manufacturing operations.Bachelor Degree in a technical subject2 years medical device QA experience with demonstrated knowledge of ISO 13485, and/or ISO9001 and FDA 21CFR Part 21 Quality System RegulationKnowledge of 21 CFR Part 820 FDA Quality System Regulation and its application and implementation. Knowledge of ISO 13485 Quality System and its application and implementation.Knowledgeable in principals and applications of SPC, IQ/OQ/PQ, sterilization, inspection, testing and quality principals.Able to supervise and organize QA personnel to provide support and coverage in support of production activities and schedules.