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Job Information

Philips Senior Quality & Regulatory Manager in Latham, New York

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In this role you will be part of the Imaging Components Q&R leadership team, and will have direct responsibility/accountability for the performance of the Magnets components business. A strong support relationship exists with the Magnetic Resonance business, where this role is expected to strongly partner with to deliver business results and drive resolution to quality related issues.

You are responsible for

  • Ensuring that all products to be released comply with all the relevant safety and environmental policies and regulations by implementing requirements, conditions and enables in the business.

  • Establishing operational objectives and work plans, and delegates assignments to subordinates.

  • Leading senior management reviews to determine success of operation.

  • Developing, modifying and executing company policies that affect immediate operations and may also have company-wide effect.

  • Leading a team of design quality engineers, and interfaces with quality business partners in ensuring quality system, supplier quality, operations quality, and complaint handling activities are properly prioritized and completed effectively on-time.

  • Acting as Management Representative for ISO 9001 and ISO 14001

  • Acting as Management Representative of the ASME Quality Program

  • Acting as Management Representative of the Pressure Equipment Directive Quality Program

  • Directly overseeing Design Quality Engineering function.

  • Coordinating with Operations Quality Engineering and Supplier Quality Engineering Teams to drive continuous improvement

  • Ensuring compliant and effective QMS’s are maintained.

  • Managing and harmonizing all QMS management processes.

  • Managing (local) Q&R processes and ensuring (local) process ownership for all activities under the QMS.

  • Ensuring Q&R requirements are effective in all processes in scope.

  • Ensuring Document Control is established and ensures training profiles are assigned and enforced and training administration are established

  • Being the key point of contact for local implementation of E2E initiatives.

  • Maintaining, enforcing, and managing a compliant and effective QMS for the activities in scope, as well as for effective and lean QMS structures.

  • Ensuring proper audit planning and schedule meets the requirements of internal policies and external regulations.

  • Ensuring CAPA process meets QMS requirements.

  • Overseeing complaint resolution process.

  • Ensuring training and training registration as per the QMS.

To succeed in this role, you should have the following skills and experience

  • Bachelor’s degree required (preferred in a technical area). Master’s degree preferred.

  • 10+ years of related experience required (medical device experience preferred – ISO 13485/FDA).

  • Proven track record of leading teams in a matrix environment.

  • Six Sigma/Lean certifications preferred

  • Ability to communicate effectively and efficiently across the organization.

  • Ability to build strong networks across the organization, and position Q&R as an enabler of business goals through building strong partnerships.

  • Uses professional concepts and company objectives to resolve complex issues in creative and effective ways.

  • Ability to establish a vision & strategy, and further segment that into actionable activities that provides clarity of purpose and clarity of direction for the entire organization.

  • Ability to drive engagement across all levels of the organization.

  • Ability to provide clarity & prioritization to the organization, in a highly complex environment.

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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