This role is focused on providing expertise and guidance to the business in interpreting and executing against applicable Risk Management, CAPA and Customer Feedback quality system elements. To ensure compliance and certification to ISO 13485 for the LSG QMS during our upcoming surveillance audit with NQA.
- Oversee CAPA program including leading CAPA Review Board meetings, reporting CAPA process metrics and working with CAPA owners to plan and document investigations, action implementation and effectiveness verification on time and according to procedure.
- Advise, coach and mentor cross-functional teams with the implementation of appropriate root cause analysis techniques.
- Present CAPAs during external audits and Quality Review Board Meetings as requested.
- Analyze quality monitoring data sources and apply statistical techniques to ensure that recommendations for the initiation of new CAPA are based on valid statistical methods.
- Work effectively with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available.
- Evaluate and improve QMS procedures and training materials as required.
- Support other quality and compliance activities as required including supporting audits and inspections.
- Bachelor’s degree or equivalent in a related technical discipline.
- 5+ years experience or equivalent combination of education and experience.
- Thorough understanding of ISO 13485 and GMP regulations is preferred.
- Quality Engineering, Six Sigma Green or Black Belt Certification preferred.
- Working knowledge of the device/drug/biotech manufacturing process.
- Skilled in statistical methods, statistical process control, and sampling plans.
- Experience working with Power BI and/or Minitab is preferred.
- Understanding of risk management regulations, principles, and application.
Hercules, CA, USA
09 Apr, 2019