In this role, you have the opportunity to
Help build a high growth business that will help improve the lives of millions of people while advancing Philips journey as a global leader in Health Technology.
You are responsible for:
Manages and maintains a compliant and effective QMS for the activities in scope as well as for effective and lean QMS structure and documents for Q&R processes in scope.
Creates PQMS awareness level as determined within the organization; contributes to BG PQMS strategic plan.
Executes PQMS standardization; ensures strategic plan (Hoshin) completion for areas of responsibility, owns all activities under the PQMS governance in scope and manages deployment.
Manages compliance to FDA regulations and other Regulatory Agencies as required, guidelines and policies in scope are consistent with those regulations.
Accountable to manage and harmonize all QMS management processes.
Manages (local) Q&R processes in scope; represents Philips during regulatory inspections/audits; oversees and manages inspections/logistics
Ensures Q&R requirements are effective in all processes in scope.
Ensures Document Control is established and ensures training profiles are assigned and enforced and training administration is established within scope.
Involved in developing modifying and executing QMS documents in scope that affect immediate operations and may also have company-wide effect.
Regularly interacts with senior management.
Establishes operational objectives and work plans, and delegates assignments to subordinates.
Establishes and assures adherence to schedules, work plans and performance requirements.
Manages individual contributors.
To succeed in this role, you should have the following skills and experience
Bachelor’s degree. plus a minimum of 10 years of related experience in the medical device or another regulated industry
Expert understanding and application of appropriate global medical device regulations, requirements and standards, including FDA’s
21 CFR 820, ISO 13485, EU Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese
MHLW Ordinance 169, ANVISA, ISO 14971, ISO 9001, and others including familiarity with the European Medical Device Regulation MDR 2017/745.
Experienced Manager with proven success leading teams and delivering on organizational objectives
Proven experience in Quality Management System processes, including cross sector or business process standardization, ensuring effectiveness and efficiency while maintaining compliance with worldwide regulations
An ability to successfully communicate and educate Quality Management System regulations, policies and strategies to teams at all levels of the organization
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
Project Management (development of project plans, status meetings, project reporting, etc.) and organizational change management
Executive communication skills; ability to prioritize and manage multiple simultaneous programs/projects
Ability to travel up to 25%
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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video .
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech/philips-recruitment-process.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .
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.