Director, Q&R Audit & Compliance Details

Director, Q&R Audit & Compliance

LaborView - Remote

Employment Type : Full-Time

If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may contact 888-367-7223, option 5, for assistance.

In this role, you have the opportunity to:

Responsible for the development and maintenance of global Q&R Compliance Audit or Q&R Compliance Facilitation programs, plans and initiatives.

Provide oversight and management of the programs, as well as leadership and mentoring to the Internal Audit staff.

You are responsible for:

• Accurately completing all assigned audit activities & assisting to assure that management is effectively advised of requirements that are vital to establish / maintain compliance with applicable US & international regulations / standards.
• Performing assessments and evaluations of internal controls, risk management, compliance profile assessment and subsequently reports its findings and recommendations to senior management, thereby addressing the strength of internal control systems, improving the cost-effectiveness and efficiency of operations and maintaining accurate accountability for compliance while handling risks appropriately.
• Drive preparation of the report for each engagement ensuring findings, action items and recommendations are practical and meaningful. Communicate effectively with internal and external management to align on audit observations and recommendations.
• Building strong partner relationships at all levels of the organization, influencing people with different agendas to embrace new concepts and different ways of working, particularly as it pertains to improving Philips’ compliance profile.

You are a part of:

As a result of Philips renewed dedication to Quality, it has recently restructured its organization to ensure you and your department have clear works 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.

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

• 10+ years of Quality Management and Quality System Auditing/Training within the medical devices industry.
• 5+ years’ of management experience
• 5+ years’ experience in audit/inspection preparation/remediation activities, or equivalent training
• Experienced understanding 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.
• Understanding of medical terminology and familiarity with standards of care and disease states.
• Successful interface management with external parties (e.g., Medical Device Notified Bodies and Regulatory Authorities, Healthcare Q&R Service providers, etc.).
• 10+ years of validated experience in a clinical compliance or equivalent role.
• Understanding of CFR, ISO and ICH guidelines governing clinical research, and of applying principles of 21 CFR Part 11 to clinical systems.
• 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

A path towards your most exciting career. Philips is growing its marketing capability enterprise wide. Succeeding in this global role in a sophisticated 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. 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 race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.

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.

Equal Employment and Opportunity Employer/Disabled/Veteran

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