Supervisor QA Engineering

Supervise, mentor, and train QA Engineering Technicians on quality procedures and standards. Assign and schedule quality tasks and inspections based on production timelines. Provide performance feedback and conduct employee evaluations. Ensure compliance with company policies, safety protocols, and regulatory requirements. Oversee product inspections, testing, and measurements throughout the production process. Review and analyze testing data and quality reports to identify trends or areas for improvement. Implement corrective and preventive actions (CAPAs) as needed to address quality issues. Perform root cause analysis on product defects or non-conformities and implement corrective actions. Identify and recommend process improvements to enhance product quality and operational efficiency. Lead continuous improvement projects to optimize testing methods and reduce waste. Maintain accurate records of quality inspection results and documentation related to product batches. Ensure proper documentation of product deviations and non-conformance reports. Prepare regular reports on quality metrics, including failure rates, defect trends, and test results. Ensure that all products and processes comply with industry standards, such as ISO, FDA, GMP, or others as applicable. Assist with internal and external audits related to quality assurance activities. Stay updated with industry regulations and standards to ensure company compliance. Collaborate with QA, production, engineering, and supply chain teams to resolve quality issues. Communicate quality performance to upper management and participate in meetings to provide updates on quality activities. May assure compliance to in-house and/or external specifications and standards (i.e. GLP, GMP, ISO). May supervise and administer specific aspects of the quality system. Some examples include Auditing, Calibrations, CAPA, Customer complaint processing, Document control, Nonconforming materials, Process controls, Receiving inspection, Training. Improves systems and processes that improve product safety; increase product consistency and conformance to requirements; improve production efficiency; reduce operating and scrap costs. Coordinates the disposition of nonconforming materials with the Materials Review Board. Reads, writes, and understands specifications and inspection criteria to apply criteria using appropriate and properly configured inspection tools. Reviews schematics and mechanical drawings. Applies proficient computer skills in the use of Microsoft Office and database applications (e.g. Excel). Assumes and performs other duties as assigned. This position may manage a small group of individuals (QA Engineering Technicians and Inspectors). Administer supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO 13485 Quality management systems) Medical device or regulated industry experience. Bachelor's degree and minimum 5 years of related experience; or 3 years and a Master's degree; or a PhD without experience; or equivalent combination of education and experience. Medical Device experience preferred.