HeadofQ&R-ChiefTechnologyOfficeatPhilipsinAndover,Massachusetts

Philips
Philips Life is better when you are you
7d Career Job

Job Title

Head of Q&R - Chief Technology Office

Job Description

In this role, you have the opportunity to

Lead the Q&R strategic direction for connected care’s Chief Technology Office

Determine regulatory strategies for advanced innovation of new products in worldwide markets

Support deployment of critical product development and lifecycle management processes and tools

Support clinical and feasibility evaluations for new product technology and solutions

You are responsible for

  • Manage, lead and implement strategic remediation efforts while effectively collaborating and driving cross functional teams and project owners.
  • Lead Quality & Regulatory strategy and execution of Advanced Development to PDLM
  • Formulate the medium term policy for the Q&R area and processes results into a strategic plan.
  • Overall control of planning, staffing, budgeting, managing expense priorities, and recommending and implementing changes to methods.
  • Create and deploy Quality strategy for business management and quality systems to ensure consistent, standardized execution of Philips Excellence Process Framework processes.
  • Oversee the Quality management representatives for all key regulatory agencies for product safety and quality (e.g: US FDA).
  • Develop and maintain an effective working relationship with US FDA and other international regulatory bodies & competent authorities.  Ensures that the organization’s products meet customer requirements and applicable quality standards.
  • Ensure that all products to be released comply with all the relevant safety and environmental policies and regulations by implementing requirements, conditions and enablers in the Business.
  • Participate with other senior managers to establish strategic plans and objectives. Makes final decisions on administrative or operational matters and ensures effective achievement of objectives.
  • Report status and risks to senior leaders and maintain and report key process and product metrics
  • Participate in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Ensures budgets and schedules meet corporate requirements.
  • Develop territory plans and participates in strategic and tactical planning.  Regularly interact with executives and/or major customers.

You are a part of

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.

 The Chief Technology Office (CTO) is part of Innovation & Strategy. They play a strong initiating and orchestrating role in innovation across businesses and markets and lead game-changing innovation that disrupts and crosses boundaries in health technology. Our goal is to create stronger alignment across Philips on topics including innovation strategy, portfolio management, integrated solution roadmaps, software & platform harmonization, software engineering, and competency management.

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

  • Bachelor’s degree required in science or engineering fields. Master’s preferred.
  • Strong management skills in a challenging working environment with a proven track record of 10+ years of experience in managing and transforming a large team
  • Expert knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, and ISO 9001.
  • Demonstrated 483, Warning Letter, and Consent Decree Remediation Leadership.
  • Strong leadership skills and demonstrated ability to influence change and challenge status quo with respect to opportunities for improvement
  • Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills
  • Advanced problem-solving, organizational, analytical and critical thinking skills
  • Ability to manage competing priorities in a fast paced environment
  • Ability to serve as best practice/quality resource within own discipline or as technical expert on functional or cross-functional teams or projects
  • Proven ability to lead cross-functional, diverse teams with competing goals

  • US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

In return, we offer you

The opportunity to truly implement difficult change within a large group in the organization. This is a highly visible opportunity with extensive room and opportunity to grow in the executive level.

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. 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 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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(Note: To ensure fairness and legal compliance in our recruitment processes, only technical issues will be monitored through the above inbox. Please do not submit resumes or applications to this email, as they will not be reviewed. Only applications received through the online application process will be considered.)

 

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Philips
Life is better when you are you

Philips is a world leading health technology company with a vision to make life better for people worldwide through meaningful innovation. Making good on this promise depends on our inclusive, passionate, inspirational, collaborative and diverse team.



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