Mentor Medical Systems is recruiting for a Quality Systems Analyst (CAPA and NC Site Lead), located in Leiden, The Netherlands.
The Quality Systems Analyst is the NC and CAPA Site Lead. The Quality Systems Analyst ensures the continuous education, implementation and improvement of Quality Systems and compliance with QS regulation and ISO standards within the Leiden facility. The Quality Systems Analyst ensures that the Leiden plant NC and CAPA processes and structure meet all business and regulatory requirements.
- Ensures the overall management and effectiveness of the NC and CAPA processes.
- Represents the site on the worldwide NC and CAPA teams.
- Works optimally with other NC and CAPA site leaders to ensure consistent systems and processes.
- Organizes and leads the Data Review Board (DRB).
- Provides education and training as needed regarding the NC and CAPA processes, including bounding and failure investigation/ problem solving.
- Ensures compliance of NC process, CAPA process
- Leads and participates in quality system improvement initiatives.
- Determines root causes of quality issues and develops corrective action and recommendations.
- Backup on other tasks within QS department to assure business continuity, if required.
Experience and Skills:
- University / bachelor’s Degree or Equivalent
- Requires a minimum of 2 years related experience. Medical device manufacturing experience preferred.
- Able to communicate and writing skills in English.
- Mathematical and analytical thinking skills
- Thorough understanding of medically regulated plant operations including knowledge of industry standards & regulations, processes and practices in a variety of different departments and operations preferred.
- Experience in taking care of audits preferred (Notified bodies and/or Competent Authorities).
- Flexibility, integrity, independency and serve minded
- Ability to work independently and in teams
- Ability to communicate effectively, orally and in writing, with employees of various disciplines and departments.
- Ability to maintain accuracy, consistency and quality of documentation and projects.
- Strong communication, human relation, problem solving and analytical skills.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to write and communicate in English and preferably in Dutch.
- Lean/Six Sigma Green Belt is desired for this position.
Mentor Medical Systems, B.V. (8808)Job Function