In this role, you have the opportunity to
Assure international regulatory and legal compliance of the Philips quality system(s) and company-wide compliance with Philips quality policies, quality objectives, and quality standards. You will be responsible to perform timely, detailed, and independent internal quality management system (QMS), and product-focused audits to assess regulatory compliance to applicable local and international regulations/standards and Philips requirements.
You are responsible for
Plan, coordinate, and execute internal QMS and/or product-focused audits to assess the
compliance and effectiveness of the overall QMS of the organizational unit(s) under audit.
Review responses to audit findings for completeness and effectiveness.
Actively promote a quality and regulatory compliance culture within Philips Healthcare by creating an environment, in which open discussion and reporting of concerns is promoted and encouraged (lead by example!)
Prepare and present timely summaries of internal audit results to various levels of Philips Healthcare management.
Travel up to 60%
You are a part of
This role with Philips Image Guided Therapy Devices team is unique because it offers the opportunity to be a part of a new internal audit program for a rapidly growing business. Additionally, we believe that people are #1 and are intentional about creating a culture that reinforces that.
To succeed in this role, you should have the following skills and experience
Certified Lead Auditor; or ASQ certification as a Certified Quality Auditor (CQA) and/or Certified Biomedical Auditor (CBA); or Certification with a recognized Accreditation body (i.e. RAB-QSA / IRCA)
BS/BA plus a minimum of 4 years’ experience in a medical device or regulated industry
In-depth knowledge of FDA’s 21 CFR 820, ISO 13485, EU Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Medical Device Regulation (EU 2017/745)
Working knowledge of appropriate global medical device regulations, standards, and requirements including Japanese MHLW Ordinance 169, , ANVISA, SFDA, Therapeutic Goods Regulations – 2002, IEC 62304, IEC 60601-1, ISO 14971
Government/regulatory-body Quality System auditing/inspection experience preferred (i.e., former FDA)
Presentation of results in a logical and clear manner
Ability to analyze information and come to conclusions based on presented data
Ability to communicate effectively both orally and in writing
Strong organizational and interpersonal skills
In return, we offer you
A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this global role in a complex environment will open many doors for your long term career, in other 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. Furthermore, Philips University is available to all employees for learning and development opportunities.
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.