In this role you will oversee the coordination of Programs, Projects and Strategic Initiatives in the Quality & Regulatory function.
You are responsible for
Applies project management methodology, best practices and standards
Monitors the competing constraints of scope, schedule, budget, quality, resources and risk
Provides a consultative role to projects and or programs by supplying templates, best practices, training, access to information and
lessons learnt from other projects
Monitors compliance to project management standards, policies, procedures and templates
Coordinating communication across projects
Can Lead quality related problem solving and root cause analysis during design and manufacturing
To succeed in this role, you should have the following skills and experience
BA/BS in life sciences required, Masters or PhD preferred
8+ years in medical device industry
Experience with FDA requirements 21 CFR 820, knowledge of regulations such as ISO 13485 and other international regulatory requirements.
Familiarity with the evolving regulatory landscape, e.g. MDSAP, EU MDR
Expert project management, business partnering and influencing skills to effectively drive Q&R strategy and initiatives.
Expert user and leverage of Q&R tools and methodologies with the ability to coach and mentor staff to build capability and self-sufficiency.
ASQ CQE (Certified Quality Engineer) or CSSBB (Certified Six Sigma Black Belt) is a plus.
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.
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 .
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.
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.