Senior Manager, Quality Assurance

What you will do

• Oversee 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 need 

• Bachelor’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 English and 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.