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Philips Complaint Investigator in United States of America - Home Based, Massachusetts

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**_Effective Tuesday, January 4, 2022, all U.S.-based employees are required to be fully vaccinated against COVID as a condition of employment at Philips

  • .  Employees may request a reasonable accommodation._**  

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.

*Montana employees are currently excluded from this requirement at this time.

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.

As the incumbent of this Quality & Regulatory (Q&R) role within Philips, your challenge will be to guide and support Business Groups, Markets and enabling functions to always do the right thing. This involves being a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve. Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our HealthTech – focused company, you will be responsible for successfully dealing with and managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA).

You are responsible for

  • Work with a variety of diverse persons within the company such as Engineers, Scientists, Clinical Specialists, Field Service & Application Engineers, and Manufacturing personnel to facilitate the complaint handling process globally

  • Evaluate customer feedback, service records, and other sources of customer and internal for possible complaint.

  • Initiate complaint in process and applicable tool.

  • Evaluate incoming data and determine if it is sufficient to understand the nature of the complaint

  • Communicate with customers, call center reps and FSEs to gather more data on complaints as needed

  • Confirm complaint condition and determine corrective action (including CAPA as needed)

  • Communicate with complainant as needed to follow up on and resolve complaint; follow up with end user/customer via complaint submitter when needed

  • Assess if the Risk assessment is covering the hazard in the complaint

  • Complete all needed records in a timely and accurate manner

You are 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

  • 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 or equivalence work experience

  • 5+ years of related experience in a medical devices or clinical experience

  • Working knowledge 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.

  • Product knowledge of CT or Nuclear Medicine preferred

  • Clinical or Technical experience in CT or Nuclear Medicine preferred

  • Ability to analyze large data populations using MS Excel or Minitab and presenting information in a clear, structured manner

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.

Our benefits can be found here: https://www.careers.philips.com/na/en/total-rewards-at-philips.

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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