The Senior Compliance Auditor is responsible for performing timely, detailed, and independent internal Quality Management System (QMS) audits to assess regulatory compliance to applicable local and international regulations/standards and Philips Healthcare requirements.
You are responsible for:
Plan, coordinate, and execute QMS audits as Lead Auditor or Auditor, to assess the compliance and effectiveness of the overall QMS of the Philips Healthcare organizational unit(s) being audited.
Review responses to audit findings for completeness and effectiveness.
Identify and share “Best Practices” within Philips.
Participate in PH Quality & Regulatory initiatives as a cross functional contributor.
Provide audit coaching/readiness training, and support for external audits.
Manage time working on multiple projects simultaneously
Open to other's ideas and work collaboratively across functions.
Plan, conduct and report internal audits according to predetermined schedule and within procedural timeframes.
Prepare and present timely summaries of internal audit results to various levels of Philips Healthcare management.
Facilitate effective corrective/preventive actions. Ensure audit nonconformances are addressed in a timely manner
Develop a thorough understanding of the complex PH organizational structure, functions, processes, and tools.
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!).
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.
To succeed in this role, you should have the following skills and experience
BS/BA plus a minimum of 5 years experience in a medical device or regulated industry
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)
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)
In-depth knowledge or experience of medical device regulatory requirements related to:
Medical devices Reports of Corrections and Removals (21 CFR 806)
Medical Device Reporting (21 CFR 803)
Risk Management (ISO 14971)
Working knowledge of appropriate global medical device regulations, standards, and requirements including Japanese MHLW Ordinance 169, ISO 9001, ANVISA, SFDA, IEC 62304, IEC 60601-1
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. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.
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.