Quality and Regulatory Compliance Lead

2 weken geleden

Nijmegen, Gelderland, Nederland Johnson & Johnson Voltijd

Are you ready to take on a unique and exciting opportunity as a Quality and Compliance Lead? Johnson & Johnson is seeking a highly motivated individual to join our team in Nijmegen, Netherlands.

This is your chance to be part of a world-class organization that is committed to innovation and delivering flawless quality in everything we do.


As the Quality and Compliance Lead, you will play a crucial role in ensuring that our operations meet the highest standards of quality and compliance.

You will have the opportunity to work with a team of exceptional professionals and contribute to the success of our goals.

With your proven expertise and leadership, you will be at the forefront of driving our quality initiatives to new heights.


Responsibilities:

  • Determine and implement quality and compliance strategies to meet organizational objectives
  • Manage the implementation and administration of quality management systems in accordance with applicable standards
  • Lead a team of quality professionals
  • Develop, maintain and lead quality systems and processes such as:
  • CAPAs and Non-Conformities
  • Change Control and Document Control
  • Quality Planning
  • Site Management Review
  • Manage Internal Audit program on site
  • Collaborate with crossfunctional teams to ensure adherence to quality and compliance standards
  • Provide guidance and support to resolve quality and compliance issues and communicates business related issues or opportunities to next management level
  • Stay informed about industry regulations and the latest approaches.

Qualifications:

Requirements:

  • Bachelor's degree in a technical or sciencerelated field
  • Experience in Medical Device Industry with proven experience in quality and compliance role.
  • Solid Understanding of 21 CFR Part 820, QSR, ISO 13485, SOR CMDR (Canada Medical Device Regulations, J-PAL (Japanese), EU-MDR (European) requirements, and knowledge of Brazil GMP and other applicable regulations and standards.
  • Outstanding leadership skills
  • Excellent communication and interpersonal skills
At Johnson & Johnson, we believe in fostering an inclusive and collaborative work environment. We value diversity and strive to create equal opportunities for all applicants and employees. We are an equal opportunity employer and encourage individuals with disabilities to apply. If you require any reasonable accommodations or adjustments throughout the recruitment process, please let us know.

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