QMS Manager (Freelance)

Develop, implement, and maintain systems to ensure products and services are designed and produced; meeting or exceeding customer requirements and expectations. Actively participate with cross-functional teams in business and engineering disciplines. Guide the business and enabling functions to always do the right thing, the first time. This involves being confident with your knowledge and effectively influencing others.

You are responsible for

• Compliance of the Quality Management System, (QMS) with relevant standards and regulations.
• Supporting timely deployment of the Philips Quality Management System (PQMS) and PIL solutions.
• Assist in achieving continued Quality System Certification by supporting both internal and regulatory agency audits; including coordinating, participating in, and conducting audits as needed. This may include, but is not limited to, quality system/ product audits.
• Performing timely and detailed CAPA engineering tasks including assessing problem descriptions, CAPA investigation, assisting with root cause analysis, and quality problem solving.
• Support QMS projects by completing assigned tasks per project schedules. 
• Review and approve quality system documents and records, ensuring GDP compliance.
• Participate in the improvement of quality system processes, documentation practices, and training.
• On-time completion of training tasks.
• Creating and distributing quality metrics when needed.
   

You are a part of
The Personal Health Team Quality Management System located in Eindhoven, The Netherlands supporting Mother and Child Care and Grooming&Beauty businesses.

To succeed in this role, you should have the following skills and experience

• Bachelor's degree in QA, Engineering or related field OR equivalent. 
• 5+ years of relevant experience in the following:
• Experience with CAPA processes including investigational techniques.
• Demonstrated ability, understanding and working knowledge of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001, ISO 14971, EU Medical Device Regulations (EUMDR). MDSAP Experience a plus.
• Solid Analytical skills - demonstrated ability to trouble-shoot complex process/system issues. 
• Experience in writing Quality Plans and Quality Agreements.
• Excellent communication, organizational and project management skills.
• ASQ CQA (Certified Quality Auditor a plus).