Senior Manager Quality & Regulatory

Job TitleSenior Manager Quality & Regulatory

Job Description

Your challenge

As the incumbent of this Quality & Regulatory (Q&R) role within Philips, your challenge will be to guide and support Business Groups, Markets and enabling functions to always do the right thing. This involves being a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.

The Senior Manager Quality & Regulatory Customer Service is accountable for establishing and improving service related organizational interfaces and processes.

This role is an essential resource supporting Customer Service and Business Groups in the development and realization of compliant and efficient service strategies and solutions.

Responsibilities

Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our HealthTech – focused company, you will be responsible for successfully dealing with and managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA).

Key areas of responsibilities (KARS) for this role include:

  • Establish and maintain relationships and networks with key Business Group and Customer Service leaders forming effective relationships and ways of working which position Quality & Regulatory as an essential and valued business partner.
  • Working closely with Business Group, Market and Customer Service representatives and Subject Matter Experts, identify service related improvement opportunities, assess risks, prioritize issues, establish solution strategies and manage change and improvement projects.
  • Manage and provide oversight to functions and programs ensuring Quality & Regulatory requirements are embedded in strategies and plans enabling the business to realize optimum results from investments bringing increased value to customers and Philips.
  • Ensure availability of resources for establishing and maintaining effective methods for managing projects ensuring deliverables are completed on schedule.
  • Ensure methods are in place and resources available for compliance risks assessments performed at program/project initiation and for mitigating risks before completion of projects reviewing project/program status at checkpoints.
  • Develop and train staff to ensure qualified and competent Quality & Regulatory resources are available to represent Customer Services Quality & Regulatory in programs and projects including cross-functional & cross organizational teams.
  • Ensure Customer Service Quality Management System documents are established (according to LEAN principles) and maintained as needed to ensure effectiveness and compliance.
  • Support regulatory and internal audits. Provide subject matter expertise during Regulatory and business partner inspections

Your team

As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.

Location: Andover, MA

We are looking for:

A person who is excited by the unique professional challenges that our Quality Transformation presents, has strong technical competencies, and demonstrates resilience challenging, often demanding situations. We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life; not just as a job. We’re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life billions for the billions of people Philips brand touches each year.

Specific skill requirements for this role include:

  • Bachelor’s degree in an engineering or science discipline, or equivalent experience
  • Extensive knowledge of global medical device regulations, requirements, and standards
  • 10+ years of related experience in a medical device or regulated industry
  • 5+ years of management experience
  • 3+ years experience managing projects
  • Expert knowledge of quality system standards and regulations
  • Strong management and influencing skills
  • Ability to take firm positions on technical issues when necessary to ensure compliance is maintained
  • Ability to communicate effectively both orally and in writing
  • Strong critical thinking skills
  • Ability to interact effectively with executives and other major (internal) customers

Our offer

This role comes with a competitive compensation offering and a generous holiday / vacation offering, but that’s not all. Quality is right on the top of Philips leadership agenda and that means you have the unique opportunity to come in and have a recognized voice to drive and witness exciting, transformational changes. You will be empowered to drive high quality, ground breaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role’s mission, you will have an array of diverse career options open to you – across different functional areas, product lines, business groups and/or geographies. That is a commitment Philips Quality Leadership team has made and stands by.

Contact

Find our more information about Philips at www.philips.com/na/careers

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.

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Contact

In case of difficulties with your job application please send an email to [email protected]


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