Job TitleQMS Manager

Job Description

Ensures compliant and effective QMS’s are established in scope of our Personal Health Business

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’sGather data and metrices for the Personal Health Regions/Center of Excellence for Management Review and other Quality Reviews requiredInternal 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 EngagementsSupport 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 environment3+ years’ practical experience with regulations and standards for medical and non-medical consumer products, pharmaceutical and/or cosmeticsStrong 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 requirementsAble to understand and analyze complex problemsDemonstrated ability to partner with the business and effectively interact with and influence employees, and managers on all levelsStrong planning, communication, and presentation skillsStrong Project Management skills, including ability to project manage QMS improvement activitiesStrong reasoning and logical thinking skillsExcellent written and verbal communication skills in English

How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
Please note that we can only offer a temporary contract for this position.

About Philips
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.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.

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