Experience:
- Over 5 years of quality management experience within the medical device, consumer healthcare, or pharmaceutical industries.
- Expertise in ISO 13485 or GMP Pharma and ISO 14971, with a preference for ISO 22000 experience.
- Extensive track record in ensuring compliance with the Medical Device Directive (MDD) and navigating the complexities of the Medical Device Regulation (MDR).
- Skilled in managing ISO 13485 or GMP Pharma Quality Management Systems (QMS) and overseeing Quality events such as Complaints, Non-Conformities (NCs), Change Controls, and Corrective and Preventive Actions (CAPAs).
- Demonstrated enthusiasm, competence, and IT proficiency in utilising SAAS-based Electronic Quality Management Systems (eQMS) for efficient quality management.
- In-depth understanding of manufacturing processes for Medical Devices or Pharmaceuticals.
- Demonstrated expertise in building strong relationships and effectively engaging with C-level executives at external (manufacturing) sites (CMOs).
- Audit and/or consulting experience, particularly related to MDR certification.
Education/Certifications/Qualifications:
- Possession of a Master's degree in Pharmacy or Biomedical Sciences, or equivalent.
- Relevant certifications and qualifications in quality management and regulatory affairs within the medical device industry.
Skills:
- Proactive and hands-on approach.
- Effective communication and influential skills across all organisational levels. Proficiency in both written and spoken English.
- Strong analytical and problem-solving capabilities.
- Expertise in process management and enhancement.
- Comprehensive knowledge of quality assurance.
- Excellent verbal and non-verbal communication skills, including the ability to train others.
- Proven capability in relationship management.
- Team leadership skills.
Other Requirements:
- Candidates must be located in the Netherlands or have strong connections there, with a valid work permit.
- Willingness to work primarily on-site, preferably for four days a week in the office.
- Possession of a valid European driver's license.
- Willingness to travel to CMOs within the Netherlands and across Europe as needed (5-10%).
