Philips Senior Director Quality and Regulatory MR in Best, Netherlands

Your challeng e

You are the driving force in making Royal Philips an industry leading organization through improved customer experience, proactive regulatory compliance and quality excellence. We are looking for a strong leader with excellent communication skills and deep content Quality knowledge. Global Experience in the medical device space is required to support a growth business. While ensuring continuing compliance, your major focus will be on driving product quality.

Your responsibilities

  • Provide leadership and direction to the Quality and Regulatory Organization in support of the MR Business Unit, including vertical supply entities and supported business units (PROS, Invivo, MR Therapy).

  • Act as the management representative for all key regulatory agencies for product safety and quality (e.g: US FDA, China FDA). Develop and maintain an effective working relationship with US FDA and other international regulatory bodies.

  • Act as Site Q&R Custodian for multi-business group manufacturing sites, such as Best, Netherlands.

  • Proactively ensure all auditable facilities (e.g: manufacturing, innovation, distribution etc.) consistently operate in a state of substantial compliance and inspection readiness; Proactively ensure all MR products, software, services and systems offered to customers and consumers consistently meet regulatory agency requirements.

  • Establish the vision and strategy for MR business management and quality systems, and practices to ensure consistent, standardized execution of Philips Excellence Process Framework processes.

  • Establish a strong core Q&R team and drives common goals and objectives to result in improved customer experience, operational excellence & proactive regulatory compliance.

  • As a people manager you are responsible to attract, develop, engage and retain your team members. You drive ambition towards our vision, act as a coach and co-own the career development plans of your team members.

  • Provides direction to senior management and leadership teams in various areas, groups, and/or operations.

  • Ensure (in alignment with key stakeholders) the right Quality mindset in the Business and the realization of Business quality targets through proactive approach to Quality (e.g: "design-in" Quality vs. inspection)

  • Proactively ensures compliance to all applicable regulations; Accountable for effective oversight on all operational processes End2End and throughout the product/software/service/systems lifecycle

  • Lead and drive effective deployment of the Philips Excellence Process Framework and Quality Management Systems (PEPF and PEQS)

  • Effectively works with the capability leaders to ensure all quality & regulatory demands are met for the business

  • Ensures that all MR products to be released comply with all the relevant safety and environmental policies and regulations by implementing requirements, conditions and enablers in the Business.

  • Participates with MR Leadership Team and other senior managers to establish strategic plans and objectives.

  • As an expert in the field, uses professional concepts in developing resolution to critical issues and broad design matters.

  • Interacts internally and externally with executive level management, requiring negotiation of extremely critical matters. Influences policymaking.

  • Requires in-depth knowledge of the functional area, business strategies, and the company’s goals.

  • Directs and controls the activities of one or more functional areas, divisions, product groups or service areas through senior managers who have overall responsibility for the successful operation of those assigned areas.

  • Business magnitude: over € 1500 M

  • Manages global or department budget over € 10 M.

  • Ability to work across all nationalities and cultures

Our offer

We welcome you to a challenging, innovative environment with great opportunities for you to explore.

Our benefits are very competitive and designed around your preferences:

  • Market conform salary

  • 25 Holidays per calendar year

  • A variable bonus based on both Philips results and personal performance

  • A company car or kilometer allowance

  • Solid company pension scheme and attractive collective health insurance package

  • Long-term incentives grant and opportunity to buy Philips shares and products with discount

  • Healthy work-life balance

Your team

The Global MR Q&R team is comprised of six business/site groups located across the world supporting MR system development, sub-level manufacturing, accessories, and final MR system manufacturing, installation and service. Direct reporting sites include Best Netherlands, Latham NY, Gainesville FL, Vantaa Finland, and Fitchburg, WI. Additional supporting activities are required with global Philips Healthtech sites in Suzhou China and Bangalore India that support MR development and/or manufacturing. Additional engagement with the Philips Diagnostic Imaging Q&R Competencies and Businesses is expected. Global MR Q&R headcount is approximately 150 individuals reporting either directly or through competency organizations.

We are looking for

  • Minimum Education & Training Requirements: Bachelor/Master’s Degree or PhD Degree in a technical discipline

  • 12-15 years of industry experience, from which at least 10 years in a regulated environment of Medical Device design and manufacturing

  • Must have senior leadership experience in various aspects of Q&R AND preferably in at least one operating process domain (Product development, Operations, Supply chain, etc.)

  • Must be familiar with business process management framework including common industry practices

  • Experience in change management is required.

  • Relevant training, experience and certification in Continuous Improvement practices such as Lean/ Six Sigma highly preferred

  • Business Acumen and strong Business Partnering Skills

  • Effective Communicator and relation builder/ networker

  • Willing to travel up to 30 to 40% (mainly to China, US and Sweden)

In this role, you have the opportunity to

Support in making Royal Philips an industry leading organization through improved customer experience, proactive regulatory compliance and quality excellence. We are looking for a strong leader with excellent communication skills and deep content Quality knowledge. Global Experience in the medical device space is required to support a growth business. While ensuring continuing compliance, your major focus will be on driving product quality.

You are responsible for

  • Providing leadership and direction to the Quality and Regulatory Organization in support of the MR Business Unit, including vertical supply entities and supported business units (PROS, Invivo, MR Therapy).

  • Acting as the management representative for all key regulatory agencies for product safety and quality (e.g: US FDA, China FDA). Develop and maintain an effective working relationship with US FDA and other international regulatory bodies.

  • Acting as Site Q&R Custodian for multi-business group manufacturing sites, such as Best, Netherlands.

  • Proactively ensuring all auditable facilities (e.g: manufacturing, innovation, distribution etc.) consistently operate in a state of substantial compliance and inspection readiness; Proactively ensure all MR products, software, services and systems offered to customers and consumers consistently meet regulatory agency requirements.

  • Establishing the vision and strategy for MR business management and quality systems, and practices to ensure consistent, standardized execution of Philips Excellence Process Framework processes.

  • Establishing a strong core Q&R team and drives common goals and objectives to result in improved customer experience, operational excellence & proactive regulatory compliance.

  • Attracting, developing, engaging and retaining your team members. You drive ambition towards our vision, act as a coach and co-own the career development plans of your team members.

  • Provides direction to senior management and leadership teams in various areas, groups, and/or operations.

  • Ensuring (in alignment with key stakeholders) the right Quality mindset in the Business and the realization of Business quality targets through proactive approach to Quality (e.g: "design-in" Quality vs. inspection)

  • Proactively ensuring compliance to all applicable regulations; Accountable for effective oversight on all operational processes End2End and throughout the product/software/service/systems lifecycle

  • Leading and driving effective deployment of the Philips Excellence Process Framework and Quality Management Systems (PEPF and PEQS)

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

  • Participating with MR Leadership Team and other senior managers to establish strategic plans and objectives.

  • Requires in-depth knowledge of the functional area, business strategies, and the company’s goals.

  • Business magnitude: over € 1500 M

  • Managing global or department budget over € 10 M.

You are a part of

The Global MR Q&R team which is comprised of six business/site groups located across the world supporting MR system development, sub-level manufacturing, accessories, and final MR system manufacturing, installation and service. Direct reporting sites include Best Netherlands, Latham NY, Gainesville FL, Vantaa Finland, and Fitchburg, WI. Additional supporting activities are required with global Philips Healthtech sites in Suzhou China and Bangalore India that support MR development and/or manufacturing. Additional engagement with the Philips Diagnostic Imaging Q&R Competencies and Businesses is expected. Global MR Q&R headcount is approximately 150 individuals reporting either directly or through competency organizations.

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

  • Minimum Education & Training Requirements: Bachelor/Master’s Degree or PhD Degree in a technical discipline

  • 12-15 years of industry experience, from which at least 10 years in a Medical Device or Pharma manufacturing environment (a couple of years Aerospace experience next to some years Medical Device experience is possible as well).

  • Must have senior leadership experience in various aspects of Q&R AND preferably in at least one operating process domain preferably operations Quality (Product development, Operations, Supply chain, etc.)

  • Must be familiar with business process management framework including common industry practices

  • Experience in change management is required.

  • Relevant training, experience and certification in Continuous Improvement practices such as Lean/ Six Sigma highly preferred

  • Business Acumen and strong Business Partnering Skills

  • Effective Communicator and relation builder/ networker

  • Willing to travel up to 30 to 40% (mainly to China, US and Sweden)

In return, we offer you

We welcome you to a challenging, innovative environment with great opportunities for you to explore.

Our benefits are very competitive and designed around your preferences:

  • A market conform salary

  • 25 Days of leave and the possibility to purchase up to 20 extra days off annually

  • A variable bonus based on both Philips results and personal performance

  • Extensive set of tools to drive your career, such as a personal development budget, free training and coaching

  • Solid company pension scheme and attractive collective health insurance package

  • Opportunity to buy Philips shares and products with discount

  • Healthy work-life balance

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.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .