CAPA Manager

Job Description

Job Title

Job Description

In this role, you have the opportunity to

Manage the CAPA program and serves as the CAPA Business Process Expert (BPE) for Philips’ Image Guided Therapy Device (IGT-D) business unit.

You are responsible for

• Leading activities to update CAPA processes to the Philips standardized processes (PEPF). Activities include, but are not limited to, creating or updating quality transition plans, coordinating and assuring availability and resources of SMEs within each Quality System, and driving execution of activities defined in the quality transition plans.
• Be the primary point of contact to develop and influence corporate Philips processes to manage CAPA activities
• Develop and implement a harmonized CAPA process for IGTD
• Manage the CAPA process for IGTD, including providing guidance and support to CAPA owners from CAPA initiation to closure.
• Manage CAPA Evaluations and Action Plans to ensure assessments and analysis are consistent across products and systems within IGTD.
• Work with cross-functional team to coordinate required activities of CAPAs

(e.g., CAPA Evaluations, root cause analysis, Investigation Action Plans, Risk Assessments, Health Hazard Evaluation documents, etc.), and ensure CAPA records are documented appropriately

• Ensure proper analysis of product quality, safety, and reliability issues under CAPA and effective communication to management and other functions.
• Ensure that processes for executing CAPAs are compliant to global regulatory requirements and meet internal quality system requirements.
• Monitor and coordinate the different quality sub-system feeders to the CAPA process such as Complaint Handling, Nonconformance Materials processes, Risk Management, Management Review, Internal Audits, etc.
• Continuously tracks CAPA actions and upcoming due dates to ensure timely completion.
• Establishes, monitors and reports on metrics on the CAPA system.
• Timely submission of CAPA KPIs for IGTD
• Represent CAPAs during audits, Management Review, and CAPA Review Board meetings.
• Continuously drive process improvements for the CAPA system.
• Maintain CAPA training program, including training for root cause analysis and technical writing.
• Monitors and enforces department compliance with company policies and procedures
• Assists in developing/maintaining annual budget for department cost center

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 collaboration 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

• US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
• Bachelor’s degree in healthcare or science fields
• 5+ years of managing CAPAs in the medical device industry
• 2+ years direct supervision of staff preferred
• Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Part 820, ISO13485, European Medical Device Directive (93/42/EEC), European Medical Device Regulation (EU MDR 2017/745 EU) Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, Brazilian Resolution RDC 23, and Therapeutic Goods Act 1989.
• Ability to work well independently and on teams in a busy department while managing multiple ongoing tasks and investigations simultaneously
• Ability to provide guidance to multiple facilities supporting CAPA processes
• Ability to leverage and/or engage others to accomplish CAPA activities
• Experience working in a broader enterprise/cross-division business unit model preferred
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
• Strong organizational and follow-up skills, as well as attention to detail
• Ability to travel approximately 10%, potentially internationally

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 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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