What you will doOversee the implementation and maintenance of the Quality Management Systems to ensure compliance with FDA, ISO 13485, and other applicable regulations and standards.
Act as a Management Representative for Tijuana Sterilization Site operations if needed.Lead and develop the Quality Operations team, ensuring training, performance management, and fostering a culture of inclusiveness, trust, and teamwork.Collaborate with site leadership, global quality teams, and operational partners to align quality objectives with business strategies and leverage resources effectively.Ensure site accreditation with regulatory rules, manage internal and external audits, and maintain compliance with quality standards, including risk management and CAPA processes.Drive quality improvement initiatives to enhance product quality, reduce costs, and improve efficiency, including implementing automation and other quality projects.Lead root cause analyses and mentor CAPA owners to ensure thorough investigations, action plans, and effective implementation of corrective actions.Support Post-Market Surveillance activities, including Medical Device Reporting (MDR), and provide timely reporting on trends and QMS performance.Partner with internal and external stakeholders to ensure timely resolution of non-conformances and share best practices across sites.Ensure the organization meets or exceeds customer requirements and regulatory expectations through effective quality planning and execution.Provide regular updates to leadership on quality performance, nonconformance management, and process improvement efforts.It will be required to work in hazardous areas and pass the initial and subsequent medical surveillance (total blood cell counts, pulmonary functional test, Chest X Rays) and require wearing respiratory protection (SCBA).What you will needBachelor's degree in a scientific, engineering or clinical discipline.At least 7 years work experience in Quality Assurance in a medical device manufacturing environment.Experience with FDA and international Quality System rules, regulations, including planning and implementation.3 to 5 years' experience in managing technical personnel and complex activities.Fluent in both Englishand Espanish required.Quality Systems knowledge (QSR, ISO 13485: 2016, MDD).Certified Auditor.Six Sigma Green Belt or Black Belt.Proficient in Microsoft Word, Excel, Power Point, Outlook.Systems knowledge is a plus (MES, SAP, onePLM, Trackwise, Valgenesis among others).Database Management and Statistical software (e.G.
MiniTab) is recommended.#J-18808-Ljbffr