Job Title
Complaint Risk Analyst

Job Description

EffectiveTuesday,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 contact888-367-7223, 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

As the Complaint Risk Analyst, you are responsible for supporting the Philips Risk Management process by conducting complaint risk assessment activities on commercialized products within Image Guided Therapy Devices. You will work closely with the Quality Engineering department and other departments as needed.

You are responsible for

• Leveraging FMEAs and risk files to evaluate the risk related to a particular complaint.
• Identifying and escalating issues such as new failure modes, new hazards, etc.
• Completing complaint risk assessments on various medical devices.
• Supporting the risk management processes throughout the product lifecycle through post market surveillance in accordance with Philips processes and global standards.
• Supporting and maintaining quality system processes relevant to the department in accordance with Philips global quality system requirements and applicable US & international regulations.
• Supporting post market surveillance processes through the analysis of field performance, identification of trends and risks, and actions to eliminate or mitigate adverse post market issues.
• Developing a mastery of our products, complaint data analysis, post market surveillance analysis, and risk analysis to enable the Philips E2E risk management process.

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

• AS/AAS/BS in Engineering Technology, Sciences, or related field is preferred, but not required.
• Previous experience in Quality Assurance, Complaint Handling, or similar in a highly regulated industry is preferred.
• Knowledge of quality systems, regulatory requirements, and industry standards.
• Experience with IS0 14971, 21 CFR 820, ISO 13485, and EU MDR is desired.
• High level of personal accountability and integrity.
• Highly detail oriented and organized.
• Excellent communication & teamwork skills.

In return, we offer you

The ability to collaborate with, learn and grow from colleagues in a highly complex, global organization where you can use your strengths to help drive strategic business initiatives for Philips. Additionally, we provide you a dynamic working environment in an innovative business, paired with a competitive salary, excellent benefits, and a supportive atmosphere where you can sharpen your talents with new challenges and career opportunities.

Enjoy endless opportunities to learn and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already. Please help us determine what's next. Your ideas and ability to deliver will help to transform the future of healthcare and allow you to create your own legacy.

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

Company relocation benefits will not be provided for this position.

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.

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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 Opportunity Employer/Disabled/Veteran