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Job TitleQMS Manager / CAPA Manager - Philips - Drachten
Job Description

In this role, you have the opportunity to make life better

Ensures compliant and effective QMSs are maintained in scope. You are responsible for the transformation of all current QMSs parts in scope towards the single PQMS structure. And you are accountable to manage and harmonize all QMS management processes.

Manages (local) Q&R processes and ensures (local) process ownership for all activities under the PQMS governance in scope.


You are responsible for:

Ensures Q&R requirements are effective in all processes in scope.
Maintains, enforces, and manages a compliant and effective QMS for the activities in scope, as well as for effective and lean QMS structures and documents for Q&R processes at all levels.
Locally manages plans for all QMS parts in scope while maintaining compliance and effectiveness throughout the duration of any changes or transitions for or in the QMS.
Ensures the addition and management of any local QMS documents in line with the evolution PQMS.
Acts as QMS competence expert, coaching and developing skills and knowledge within the QMS team.
Ensures training and training registration as per the QMS and generates training content for local QMS documents as necessary.
Responsible for driving CAPA activities from issue identification to closure, effectively project managing all CAPA activities, ensuring the quality of CAPA record content and representing CAPAs during audits and CAPA Review Board meetings.
Responsible for independently managing and completing CAPA records, analyzing data, and advising on quality issues in compliance with relevant standards. Contribute to maintaining high-quality standards and compliance within the organization.
Manage all aspects of CAPA activity which includes gaining the commitment of cross functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines
Represent CAPAs during audits and CAPA Review Board meetings.
Lead and mentor cross functional teams with the implementation of appropriate root cause analysis techniques.
Work effectively with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available.


You are a part of

Professional QMS Team, with multiple team peers and you are based in Drachten.


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

Education: Bachelor degree.
Experience: at least 3 - 5 years of QMS management experience in medical device, consumer products industry or food contact material industry.

Competencies and Skills:
Good communication effective written and oral communication skills, organizational and project management skills
Be familiar with ISO 13485, ISO 9001, 21CRF 820, GMP and European Food contact legislation
Excellent organization and coordination.
Experience in Change Management.
Experience of leading a team is preferred.
Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions.
Advanced Analytical Skills; demonstrated ability to troubleshoot complex process/system issues.


Please note: For this position we do not offer relocation support.



In return, we offer you
A path towards a most rewarding career. Philips is growing its capability enterprise wide. Succeeding in this role in a complex environment will open many doors for your long-term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities.


Recruitment Process

If you are interested in this opportunity to join us, please read the complete job description on our website and upload your
resume and motivation letter
through the Philips career site- vacancy number
510187.



Please note that the closing date of this vacancy is Wednesday, 3 April 2024.


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 here
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Discover our rich and exciting history here
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Learn more about our purpose here
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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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