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QMS Manager

QMS Manager

LocationUtrecht, Netherlands
Business SectorMedical Devices
Contact nameGemma Dozy
Contact email
Job ref22953
Published16 days ago
Senior QMS Manager 
Location: Utrecht, Netherlands
Type: Permanent, Full-Time

For an innovative hybrid Medical Device and Pharma company, we are seeking a QMS Manager with a focus on Quality Management Systems and driving change management. 

Core Responsibilities:
  • Shape and enhance the future QMS and eQMS in alignment with rapid company scale-up and diversification.
  • Drive compliance with ISO 13485, US 21 CFR, EU MDR, and MDSAP, while maintaining and achieving relevant QMS certifications (CE, EN-ISO 13485, MDSAP).
  • Lead the selection and implementation of eQMS solutions that integrate seamlessly with existing ERP systems.
  • Develop and enforce process ownership within QMS subsystems, ensuring robust performance and attainment of Quality Objectives.
  • Author QMS processes and SOPs, acting as a delegate to the VP of Quality and Regulatory Affairs.
  • Oversee the quality agreement processes for outsourced manufacturing and ensure compliance across all platforms.
  • Participate actively as a member of the Change Management Board, endorsing QMS process changes and document modifications.

Profile:
  • Bachelor’s degree with over 7 years of experience in QMS management within large-scale and complex organizations.
  • Proven track record in ERP and eQMS implementations, including Computer System Validation.
  • Extensive experience with Lean or Agile methodologies and adept in managing significant changes.
  • Strong leadership skills with a history of positive stakeholder feedback and demonstrable results.
  • Preferably holds an MSc degree and lead auditor qualifications.
  • Medical Device industry experience highly preferred, with knowledge in managing cleanrooms and sterilized products.
  • Fluent in English; Dutch is beneficial.
  • Ability to work onsite at least 60% of the time.

Offer:
  • Direct permanent contract with an initial term of 12 months.
  • Bonus and benefits package.
  • Hybrid working model, providing flexibility between onsite and remote work.
  • Opportunity to contribute to a rapidly growing and innovative company at the forefront of medical device technology.

Interested?

If you're interested or know someone who might be a perfect fit, don't miss out on this unique opportunity. Reach out today. Please contact 
Gemma Dozy on g.dozy@panda-int.com.