Philips Senior Manager, Quality & Regulatory in Cambridge, Massachusetts
In this role, you have the opportunity to
As the incumbent of this Quality & Regulatory (Q&R) role within Philips, your challenge will be to guide and support CTO (Chief Technology Office) venture teams 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.
You are responsible for
To formulate and implement the CTO venture team’s long-range quality, regulatory and compliance policy
Create quality and compliance awareness level as determined within the CTO venture teams.
Enforces (a simplified) quality systems and harmonizes them across the Business sites and Sector; establish an effective Management Review including routine reporting.
Introduce and implement the quality processes and tools required to ensure product quality and customer satisfaction.
Manages compliance to applicable regulations and Regulatory Agencies as required, guidelines and policies to all products and operations are consistent with those regulations.
Manages the review and approval of finished products manufactured for and by the company in accordance with their approved specifications. Includes Complaint handling.
Manages all inspections and questions relating to the operation of the design & development / manufacturing sites in coordination with all other applicable company groups.
Direct the Audit Program for the organization.
Drafts and manages the quality strategic improvement in CTO
Interact with all areas involved in the product development process, customer services and sales and marketing and provide direction and consultation.
Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals.
Provide guidance to subordinates within the latitude of established company policies.
Formulates and recommends (changes to) policies and establishes procedures that affect immediate organization(s).
Manages the coordination of quality activities within the CTO teams.
Has budget responsibilities.
You are a part of
CTO Quality 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.
To succeed in this role, you should have the following skills and experience
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.
Bachelor degree or above in engineering/science
Minimum of 6 years’ Q&R management experience in Medical Device Design and Development, Manufacture or commercial organization , at least 2 years’ experience with focus on software
Strong understanding of Medical device regulations and standards
Strong interpersonal and influencing skills as well as analytical/statistical skills
Ability to work on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends, acts as advisor to subordinate(s) to meet schedules and/or resolve technical problems.
Proven ability to lead diverse discipline teams, understand and identify relationships and interdependencies across multiple projects /functions
Must be fluent in oral and written English
ISO 13485/ISO9001 internal auditor
Experience with people management is preferred
Knowledge and experience with Agile methodology is preferred
In return, we offer you
A path towards your most rewarding career. Philips is transferring to Digital Healthcare enterprise wide. Succeeding in this role in a complex environment will open doors for your long term career, in quality and regulation, or clinical science areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities.
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.
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 .
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without 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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