Job title: Quality Systems Analyst ad interim / NCR-CAPA Site Lead
The Quality Systems Analyst is the NCR-CAPA Site Lead. The Quality Systems Analyst ensures the continuous education, implementation and improvement of Quality Systems and compliance with QS Regulation and ISO within the Leiden facility. The Quality Systems Analyst ensures that the Leiden Plant NCR and CAPA Processes and structure meet all business and regulatory requirements.
Duties and responsibilities:
1. Responsible for the overall management and effectiveness of the NCR & CAPA processes.
2. Representation of the site on the worldwide NCR and CAPA Teams.
3. Organize and lead the CAPA Review Boards.
4. Provide education/training as needed regarding NCR & CAPA processes including Bounding, and Failure Investigation/ Problem Solving.
5. Ensures compliance of NCR process, CAPA process and assigned projects with the FDA Quality System Regulation, ISO13485, MDD, CMDR and other industry standards as applicable.
6. Responsible for analysis of complex statistical methods, quality tools and computer-generated reports to continuously improve process capability.
7. Leads and participates in quality system improvement initiatives.
8. Determines root causes of quality issues and develops corrective action and recommendations.
9. Establishes, maintains and implements communications to increase awareness and promote improvement of quality issues across the business.
10. Report NCR/CAPA scorecard results, as needed.
11. Ensures quality systems are effectively deployed and performs periodic checks to verify appropriate application.
12. Performs other duties assigned as needed.
Experience and education:
University / bachelor's Degree or Equivalent years of experience
Able to communicate and writing skills in English.
Mathematical and analytical thinking skills
Requires a minimum of 2 years related experience. Medical device manufacturing experience preferred.
The position may require interactions as subject matter expert with government agencies, competent authorities, third part suppliers or customers.