In this role, you have the opportunity to
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. This position is part of the Business group, Philips Oral Healthcare, Philips Quality Management System, (PQMS) located in Bothell, Washington
To succeed in this role, you should have the following skills and experience
- Bachelor’s degree in QA, Engineering or related field OR equivalent.
- 7+ 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).
- Basic understanding for Non-Product System Software Validation
In return, we offer you an opportunity to work in the medical industry, which brings much fulfillment, as well as unique opportunities to grow. By taking pride in all you do and inspiring others around you to prioritize quality above all else, you’ll be contributing to a higher Quality of life for billions and helping Philips deliver innovation that matters.
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.
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.
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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