Philips QMS Manager 

Netherlands, North Brabant 

271694876

QMS Manager

Your role:

• Execute the Personal Health QMS translation process, including criteria for when translation is required, adhering to local Regulatory requirements, Labor Laws and Works Council Agreements.
• Manage relationship with Personal Health Regions/countries point of contacts, where translations are required to address any queries and glossary approvals from vendor regarding translation.
• Manage relationship with translation agency, regarding the translation process and queries and act as the Personal Health representative for co-creation and improvements of the translation process.
• Work with the PH QMS Document and Change Control team, managing upload of translated content to the Personal Health QMS’s
• Gather data and metrices for the Personal Health Regions/Center of Excellence for Management Review and other Quality Reviews required
• Internal audit engagement planning for the 5 Personal Health Regions and 2 Center of Excellences, ensuring the availability of required Subject Matter Experts across the Regions/Countries.
• Increase awareness and understanding in the Personal Health Regions/Center of Excellence organization of the Regulatory Landscape applicable to Personal Health Quality Management Systems and Do’s and Don’t during Audit Engagements
• Support QMS projects, related to Personal Health Regions/Center of Excellences

You're the right fit if:

• At least a bachelor’s degree in an engineering or scientific-related field or other equivalent technical experience working in a consumer business and/or medical device environment
• 3+ years’ practical experience with regulations and standards for medical and non-medical consumer products, pharmaceutical and/or cosmetics
• Strong understanding of appropriate global regulations, requirements, and standards such as FDA 21CFR Part 820/Part 11, ISO 13485, EU MDR, EU Annex 11 and ISO 9001.
• Preferred knowledge of ANVISA, CDMR, TGA, MFDS, MHLW, CFDA, TFDA and ISO 14971 requirements
• Able to understand and analyze complex problems
• Demonstrated ability to partner with the business and effectively interact with and influence employees, and managers on all levels
• Strong planning, communication, and presentation skills
• Strong Project Management skills, including ability to project manage QMS improvement activities
• Strong reasoning and logical thinking skills
• Excellent written and verbal communication skills in English

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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