Senior QMS Manager Location : Bilthoven, 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.

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