In this role, you have the opportunity to
In this role you will have the opportunity to develop the Quality Management System (QMS) for Population Health Management (PHM) Venture that complies with the appropriate standards and regulations and with Philips QMS procedures and standards. The PHM Venture is comprised of products that are regulated by FDA/ISO 13485 and others that are Healthcare IT. The QMS Manager will prepare and host internal and external audits and drive corrective actions accordingly for audit findings. They will also work with a dedicated team of Quality professionals to implement best practices and continuously improve the QMS .
You are responsible for
- Developing a QMS for PHM Venture and manage the deliverables per project timeline.
- Providing compliance guidance across the business as needed. Primary areas include quality system changes, large-scale projects, day-to-day general questions.
- Lead capa review board meetings and driving timely completion of capas
- Responsible for training metrics for the business unit
- Drive local QMS transformation towards harmonized and standardized Philips QMS
- Manage internal and external audits and drive corrective actions for audit findings.
- Work with a cross functional team to develop and implement corrective actions to audit nonconformances identified during internal/external audits in a timely manner. Manage audit corrective action systems.
- As appropriate mentor quality team members.
- Input KPIs in the database and as necessary develop action plans to meet KPI goals (complaints/CAPA/FCO/audit findings, etc.)
- Performing other duties as required.
You are a part of
Philips Population Health Management which is an emerging market need that is leading Population Health Management for Philips. The Q&R team is very team centric and comprised of industry leading products that are regulated by FDA/ISO 13485 and non-regulated.
To succeed in this role, you should have the following skills and experience
- Bachelor's degree and at least 5 years of applicable experience required
- Knowledge of 21CFR820, ISO 13485, ISO 9001 and ISO 14971 required
- Experience as a lead auditor and in supporting/managing audits
- A good understanding of development of Quality Management systems.
- Ability to think of the big picture, while taking measure to ensure tactical deliverables in a timely manner.
- An ability to successfully communicate and educate Quality Management System regulations, policies and strategies to teams at all levels of the organization
- Clear and effective verbal and written communication skills required
- Excellent interpersonal & time-management skills are required
In return, we offer you
Describe in two to three lines what tangible and intangible benefits the incumbent will gain in this role. Use our Employer Value Proposition (EVP) themes and information gathered in the RSM as input sources.
Why should you join Philips?
Working at Philips is more than a job. It's a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it's like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog . Once there, you can also learn about our recruitment process , or find answers to some of the frequently asked questions .
Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223 , option 5, for assistance.
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