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Philips CAPA Engineer in United States of America - Home Based, Massachusetts

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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.

Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.

But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common: An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.

The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.

In this role, you have the opportunity to make life better

Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.

In this role, you have the opportunity to

Support CAPA execution for the North America Market QMS by coaching and guiding CAPA owners through the process as well to ensure compliance to CAPA quality standards. You will act as a CAPA subject matter expert who can confidently advise and critically review Corrective and Preventive Actions (CAPAs) in various stages of the CAPA workflow and facilitate CAPA investigations from issue identification through implementation of solution and effectiveness monitoring.

You are responsible for

  • Facilitate Corrective and Preventive Action (CAPA) and nonconformance (NC) investigations from issue identification through the implementation of solution and effectiveness monitoring.

  • Project manage all aspects of CAPA and NC activity which includes gaining the commitment of cross-functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines.

  • Review CAPA execution/record – assure CAPA quality standards are met before the CAPA may proceed to the next step. Ensure CAPA activities assess dependencies and risks in the QMS.

  • Mentor CAPA teams to use appropriate root cause analysis techniques and problem-solving methodologies (e.g. Fishbone, Pride problem solving). Share knowledge and helps problem-solve with systemic issues driving impact. Coach and guide CAPA Owners through the CAPA process.

  • Work effectively with all levels of management to ensure CAPA action plans can be supported and resources needed to implement plans are available.

  • Interact with multiple Quality Management System stakeholders and Senior Leadership.

  • Support the CAPA Review Board—Support intake process of CAPA Requests from feeder processes to present to the board & presenting CAPA System Health metrics for monthly reviews. Escalates issues to CAPA Review Board as needed.

  • Support and present CAPA during internal and external audits successfully.

  • Engage with the Multi-Market CAPA team, and global CAPA Community of Practice to support continuous improvement efforts in the CAPA process.

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’ll need a customer-first attitude and the following

Required

  • Bachelor’s degree in engineering, science or related field.

  • Working knowledge of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, and ISO 9001

  • At least 5+ years of experience in a medical device industry

  • Excellent people and communication skills, including the ability to express technical concepts in verbal and written form

  • Comfortable working in a dynamic and evolving environment

  • Able to influence without authority

  • Analytical mindset. Focuses on the details while seeing the big picture.

  • Able to solve complex problems by bringing ideas into action.

  • Strong project management, collaboration, and organizational skills

  • Strong aptitude for coordinating and assigning tasks

  • Enthusiastic, motivated and self-driven

Preferred

  • Quality auditor experience or working knowledge

  • Lean Six Sigma certification or working knowledge

  • Global project management experience. PMP a plus

How we work at Philips

There are three core ways that define our ways of working – embracing flexibility, being at our best, and impactful collaboration. We believe this enables us to deliver an outstanding experience to our customers and create the best place to work for people who share our passion.

We know just how important direct interactions are and work is more engaging when we are more frequently face-to-face, and that we experience better collaboration which drives innovation. While we have many different types of roles across Philips most require a combination of in-person collaboration with colleagues and partners, usually at a Philips location, and individual focus time, which can be done remotely.

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 innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.

Visit our careers website to explore what it’s like working at Philips, read stories from our employee blog, find information about our recruitment process and answers to some 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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