In this role, you have the opportunity to
You are the main interface between the QA team and development team on Risk Management. You facilitate meeting risk management goals in a compliant manner and you understand how quality policies and development processes interact. You work closely with Regulatory Affairs, Product Development, Clinical, Operations, Service, Supply Chain and Marketing & Sales.
You are responsible for
Establishing the policies/standards of the Risk Management processes, including risk analyses, risk evaluation, and control in both pre-market and post-market risk management activities to ensure a robust, closed-loop process in order to provide product safety, patient/user safety and compliance in this critical area, with an emphasis on software and/or systems engineering.
Leading the organization through change management to a centralized risk management way of working, with improvements in efficiency and optimization, while also ensuring compliance to current and future regulations.
Regular interactions with Risk Management teams and their respective senior management across all Business Groups within Philips to ensure integration and implementation of solutions.
Serves as a subject matter expert and resource within risk management discipline; technical expert on functional or cross-functional teams and projects.
Sharing Expert knowledge of Risk Management principles and practices including Safety Risk Management (ISO 14971), FMEA’s, and post-market activities throughout the organization.
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 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.
A Masters or Bachelor Degree
Must be recognized as content matter expert
Requires strong working knowledge of quality assurance principles and practices, industry and international safety standards
Minimum 5 years in medical device environment
Must practice analytical problem solving skills
Able to exercise judgment against the criteria of applicable regulations and standards
Is able to communicate the new process and system to both sr. leaders as people executing the process.
Is able to coordinate and manage activities
Proactive and able to act on own initiative
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.