Quality & Regulatory Programs Leader
Quality & Regulatory Programs Leader
In this role you will oversee the coordination of Programs, Projects and Strategic Initiatives in the Quality & Regulatory function.
You are responsible for
- Working on complex issues where analysis of situations or data requires an in-depth knowledge of the company.
- Participating in corporate development of methods, techniques and evaluation criteria for projects, programs, and people.
- Identifying opportunities for simplified quality systems and harmonizes them across the Business sites
- Applying project management methodology, best practices and standards
- Working to align corporate quality initiatives and supporting/formulating the Business' long-range quality and regulatory programs and initiatives
- Having broad expertise or unique knowledge, using skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
- Monitoring the competing constraints of scope, schedule, budget, quality, resources and risk
- Providing a consultative role to projects and or programs by supplying templates, best practices, training, access to information and lesson learnt from other projects
- Participating with other senior managers to establish strategic plans and objectives.
- Implementing strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results.
- 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 . 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 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.
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