Quality Systems Analyst

1044152 | Leiden | Quality Systems | CAPA | Medical Devices | ISO13485

Your new role
The Quality Systems Analyst is the NC and CAPA Site Lead.
The Quality Systems Analyst is responsible for 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 NC and CAPA processes and structure meet all business and regulatory requirements. Some responsibilities include:
  • Ensures the overall management and effectiveness of the NC and CAPA processes.
  • Organizes and leads the Data Review Board (DRB).
  • Assists in the development of quality metrics.
  • Provides education and training as needed regarding the NC and CAPA processes, including bounding and failure investigation/ problem solving.
  • Reports NC and CAPA scorecard results, as needed.
  • Ensures compliance of NC process, CAPA process and assigned projects with the FDA Quality System Regulation, ISO13485, MDD, CMDR and other industry standards as applicable.
  • Conducts internal audits to determine compliance with quality management system standards as well as regulatory and customer requirements.
  • Determines root causes of quality issues and develops corrective action and recommendations

What you'll need to succeed
In order to be a successful Quality System Analyst, you need to have a University / Bachelor’s Degree or equivalent in the life sciences field. It is essential to also have a minimum of 2 years of Quality Systems experience and a minimum of 3 years in similar environment with medical devices or pharmaceuticals. It would be preferred if you had a minimum of Lean/Six Sigma Green Belt and a background in Statistics. Fluency in written and spoken English, and Dutch preferred.

Your new company
Mentor Medical Systems is a worldwide renowned manufacturer and supplier of medical products. The company develops, produces and sells innovative and high-quality plastic surgery products all over the world. For the past 20 years, Mentor has developed breast implants that are used in cosmetic and medical applications. Production takes place under strict laws and regulations to ensure the highest quality. Mentor has been part of Johnson & Johnson since January 2009.

What you'll get in return
Hays Detachering | This is a project that will start with a contract for 12 months through Hays. Extension to stay within the department is anticipated. At this position, you will get a competitive salary and your travel expenses are covered.

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. #1044152
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Type de contrat
Secteur d'activité
Life Sciences
based on background + experience, Travel expense covered


Parlez à Ewa Tran, en charge de cette offre, située à Amsterdam
Hays Amsterdam, H.J.E. Wenckebachweg 210

Téléphone: 0643452976