In this role, you have the opportunity to
The Q&R Quality Assurance Specialist works to secure that the quality processes, tools and methods used within the Philips Q&R Program Management Office portfolio of projects are performed in compliance with the company’s Quality Management System (QMS) requirements. Under general direction of the Q&R Project Quality Assurance Manager, the role is responsible for writing documentation, conducting quality audits and supporting a variety of quality projects and initiatives.
You are responsible for:
Per direction from Project Quality Assurance Manager, work with Project Managers to ensure that quality oversight activities within projects are started at the right time, respected throughout the project lifecycle and driven until a successful launch of the project.
Within scope of audits and project reviews, proactively identify issues and find appropriate contacts/assistance/answers; then work with Project Quality Assurance Manager to apply solutions, or escalate as necessary.
Support the execution of the PMO's quality assurance infrastructure routines according to the Philips Quality Management System and accepted rules and standards
Execute reviews and approvals at appropriate Quality Gate stages, as assigned
Partner with Project Quality Assurance Manager to intervene as appropriate, if any activity is perceived to have a negative impact on project execution within Quality guidelines
Participate in continuous improvement project teams, determine effectiveness of improvement activities and applicability to own team.
Performs timely, detailed, and independent internal Quality Management System (QMS), project-focused audits to assess regulatory compliance to applicable local and international regulations/standards and Philips requirements.
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
3+ years of related experience in a medical device, IVD, biologics or Pharma industry.
Working knowledge of appropriate global medical device regulations, requirements, and standards
Audit training/ experience (e.g., CQA or similar type training)
Strong ability to manage projects remotely, with teams located in various sites and/or countries
A bachelor’s degree in business administration, engineering, supply chain operations, Quality Management or a related field. Comparable business experience to a bachelor’s degree will also be considered for exceptional candidates, at hiring manager’s discretion.
Familiarity with Quality Management Systems (QMS), Good Documentation Practices, Medical Device Manufacturing
Works independently and as part of a team to analyze, report, and deliver data regarding various aspects of quality assurance.
Situational Thinking: Maintain flexibility in thinking through challenges, making decisions and solving problems in a variety of situations (e.g. analytical, creative, implicative, strategic)
Ongoing Passion for Learning: Constantly develop and renew leadership and technical skillset for yourself as well as those on the team
Ability to effectively communicate detailed information and strategic decisions, and respond to questions from project stakeholders of all levels, including C-Suite Members
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.