Quality/CAPA Specialist

2 maanden geleden

Rotterdam, Zuid-Holland, Nederland Yacht Voltijd

Job description:
Yacht is looking for Quality Specialists with strong knowledge of ISO standards and CAPA to work at the large companies in the Netherlands.
In this role, you will be responsible for providing support in the following activities:

  • Root cause analyses and mentoring cross-functional teams with the implementation of this
  • Quality troubleshooting
  • Identifying causes of non-conformances, and mentoring others in this topic
  • Evaluating investigations and corrective measures
  • Assisting CAPA Owners in all facets of operations (e.g. in presenting CAPA's during audits and board sessions)
Functie-eisen

Job requirements

  • Bachelor or Master degree in Quality management, Engineering, Biomedical Sciences, Bio-pharmaceutical Sciences, Life Science & Technology, or other relevant academic field
  • >5 years of work experience in Quality roles within regulated industry, such as biotech, pharmaceutical, medical devices or similar
  • Extensive knowledge of, and experience with CAPA
  • Up-to-date knowledge of standards (i.e. ISO standards) and regulations, such as e.g. ISO 13485, ISO 9001, and ISO 14971; 21 CFR Parts 803, 806, and 820.
  • Good understanding of statistical methods and quality tools
  • Previous work experience within Manufacturing, Research & Development, or Engineering environments
Competenties

Competencies:

  • Strong communication skills in English
  • Able to build connections with stakeholders, team workers and manage across cultures
  • Well-developed coaching, training skills
  • Proactive and an entrepreneurial mindset and the ability to think 'out of the box' to create new solutions
Arbeidsvoorwaarden

Terms of employment

If you meet these criteria and are interested to be presented to our customers, please introduce yourself and send us your CV and (short) cover letter

Based on the incoming applications and availability of suitable positions, we will select and invite candidates to meet us and to explore career opportunities. Please note that we may not have a specific vacancy that matches your profile at that time, but we may receive it again in the (near) future.

We offer challenging positions which allows you to work in a dynamic and international environment, ensuring diversity in your work and creating plenty of opportunities for personal development.
This concerns a secondment contract. We have an open position for 1 year with possibility of extension and a permanent contract at the company. Full-time (40h) is strongly preferred, working 32 or 36 hours per week can be discussed. We will offer a competitive benefit package in line with your seniority and the seniority of the position

Bedrijfsinformatie

About the company:
Our clients are global leaders in health technology and pharma.
Why YACHT ?
Because of challenging positions at leading (biotech) companies, a large network and development opportunities These are the advantages of working via YACHT.
With us, you will get all the space to grow further. Together we will look for assignments that suit your ambitions and help you to realize your goals. Through coaching, for example, but also by inviting you to interesting courses, knowledge sessions and inspiring meetings.
Through us, you will get access to a network of professionals and companies that are happy to share their knowledge and opportunities with you.
The world is changing and going through transformation at a rapid pace. The labor market is constantly making new demands on professionals. YACHT knows better than any other company how the labor market is developing, and can ensure that you are prepared for these changes. Now and in the future.

We will help you to keep developing yourself within challenging projects we offer at leading organizations. At the same time, you will make a difference for our clients by realizing improvement of their products and processes. That requires quality work of professionals who are able to take on the real challenges.

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