Mentor Medical Systems is recruiting for a Quality Systems Supervisor, located in Leiden, The Netherlands.
Under the management of the local Quality Operations Director this position will have the objective of maintaining high quality standards for the product manufacturing process and compliance with all applicable regulatory requirements.
Manages the day-to-day operations of the Quality Systems staff. Coordinates the development and implementation of processes, procedures, audits and corrective actions. Ensures effective communication and training are deployed throughout the business. At this level the role has increased responsibility including, but not limited to, additional skills, multiple lines/products, diverse teams, etc.
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
- Assigns tasks and projects to staff. Tracks progress and reallocates resources as necessary.
- Supervises the implementation and administration of quality management systems in accordance with applicable standards.
- Compiles data and prepares reports on system effectiveness for management.
- Site Management review: Lead the Site Management Review process to allow meaningful review.
- CAPA: Supervise CAPA process and the CAPA Review Board meetings.
- Non-Conformance (NC): Supervise NC process.
- Record Management: Supervise Record management process.
- Change Control and Document Control: Supervise Change Control and Document Control processes.
- Mentors, coaches, trains and develops direct reports. Evaluates performance and provides opportunities for growth.
University / bachelor’s Degree or Equivalent
Experience and Skills:
Minimum of 6 years in similar environment with medical device or pharmaceutical company, with relevant QS experience.
Background in Statistics, Process Excellence is preferred.
- Excellent communication skills, able to quickly build credibility within the company and the executive management.
- Proven track record of demonstrating collaboration across the organization and at all levels
- Balanced technical understanding of products and processes combined with superior business and compliance acumen
- Mathematical skills: Able to apply mathematical concepts, such as exponents, logarithms,
- Probability and statistical inference, and fundamentals of other mathematical disciplines. Able to apply mathematical operations to tasks such as frequency distribution, determination of test reliability and validity and sampling theory.
- Ability to define and resolve problems. Collect data and analyze data, establish facts and draw scientifically valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
- Accountability, with a strong desire to commit, be held accountable and be rewarded for delivering results.
- Capacity to put the customer central to all thinking
- Ability to recognize, build support for change and engage in constructive conflict.
- High tolerance for ambiguity in a complex environment
- Ability to make the complex clear and easily understood by others
- Able to generate enthusiasm for best-in-class performance through the clear personal passion to be the best in these areas
- Ability to build partnerships both internally and externally
The primary location for the position is the Mentor site in Leiden, The Netherlands.
Expected travel percentage for domestic, international, or both -less than 5% per year.
The position may require interactions as subject matter expert with government agencies, competent authorities, third part suppliers or customers of J&J.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.Primary Location
Mentor Medical Systems, B.V. (8808)Job Function