Essential Functions and Responsibilities:Review customer complaints, conduct product investigations, and ensure proper complaint closureConduct medical device reporting assessments and investigationsDevelop sampling plans for evaluating, and reporting quality and reliability dataDemonstrate continuous effort to improve product quality and manufacturing processesParticipates on Project Team as Quality Representative. Ensures that principals of Design Control are applied to Product and Process Changes and New Product DevelopmentProvides Quality Assurance leadership for Project Teams or Quality DepartmentCreates reviews and approves Quality System Documents (ex. CAPA, Audits)Creates reviews and approves Product DocumentsCreates, reviews, and approves Protocols, Process and Product Validations, Stability Protocols, Software Validation documentsReviews and inspect Device History Records to ensure document accuracy, verify that product quality meets standards and authorize release of the product for distribution.Mentors entry point staffProvides supervision to technicians and junior engineersAssists in the review and interviews of potential candidatesCreates reviews and approves documents required for Design History FileCreates reviews and approves Risk Assessments such as FMEA, FMECA or FTAAnalyzes process and product non-conformances and implement comprehensive corrective and preventive action plansPerforms Internal or Supplier Quality System AuditsEnsures compliance to Department proceduresTracks and trends Quality IndicatorsServes as Independent QA Reviewer and Chairperson for Design ReviewsPerforms other duties, as assignedWork Experience Requirements:Quality Engineering and Customer Complaint Investigation experienceWorking knowledge of standards and regulations, including but not limited to US-FDA’s 21 CFR Part 820 and 21 CFR Part 803, and GMPMedical Device Industry experience and working knowledge of ISO-13485 preferred Quality management systems, and ISO 14971 Medical devicesEducation Requirements:Bachelor’s degree in an engineering/scientific or quality management curriculum required plus a minimum of 5 years work experience in Quality Assurance within an FDA, ISO or similarly regulated environment and/or equivalent combination of education and experienceMaster’s degree preferred, with a minimum of 2 years work experience in Quality Assurance within an FDA, ISO or similarly regulated environment and/or equivalent combination of education and experienceExperience in the development and implementation of effective Design Control Systems