Job Title
QMS Engineer

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

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.

You are responsible for

• Ensures external and internal audit readiness and provides support during external and internal audits
• Reviews QMS and Engineering changes as well as Quality plans to ensure compliance/conformance to FDA regulations and other Regulatory Agency and consensus standard requirements
• Ensures adequate service levels and quality for document control, records management, software validation, CAPA, Quality Planning, Management Review QMS processes; monitoring and assurance of process performance
• Represents QMS/Engineering Change processes and records to regulatory agencies as required
• Owns QMS CAPAs, develops adequate and defensible root cause analyses and action plans; completes plans to schedule
• Actively assists in managing a program of CAPAs; accountable for timely and comprehensive corrective and preventive management of issues/opportunities
• Actively assists in managing a program of Quality Plans; accountable for plan accuracy and on-schedule plan closure
• Proactively identifies areas of emerging risk and advises on directions for future areas of analysis/development
• Acts as QMS competence expert, coaching and developing skills and knowledge within the QMS team
• Supports the move toward the Philips Excellence Process Framework for the transformation the business to the Philips Business System including the Philips Integrated IT Landscape
• Promoting Q&R awareness level as determined within the organization
• Managing the enforcement of standardized quality systems across the Business; ensuring deployment of strategic projects & E2E PIL Solutions to schedule
• Establishing an effective Management Review process, including routine reporting
• Managing the strategic improvement processes ('breakthrough Program') in the Business (One Page Strategy, Hoshin Plan)
• Participates in Quality & Regulatory initiatives as a cross functional contributor
• Creates PQMS transformation awareness and establishes the Philips Business System, manages all activities under the PQMS governance
• Establishes operational objectives and work plans, and delegates assignments to subordinates
• Establishes and assures adherence to schedules, work plans and performance requirements
• May manage or oversee individual contributors

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

• Bachelor's degree plus a minimum of 2 years of related experience in the medical device or another regulated industry, and in the application of automated technology, particularly GAMP 5.
• Quality Management Systems knowledge, including Application and Implications: Including ISO 9001, Standards and Regulations.
• Knowledgeable of the following Medical Device standards: ISO 13485 & FDA (21 CFR Part 820), MDD/MDR
• Knowledgeable of Global Medical Device Regulations: EU Medical Device Directive (93/42/EEC); Canadian Medical Devices Regulation (SOR/98-282); Japanese MHLW Ordinance 169, ANVISA, ISO 14971; familiarity with the European Medical Device Regulation MDR 2017/745.
• Proven experience in Quality Management System processes, including cross sector or business process standardization, ensuring effectiveness and efficiency while maintaining compliance with worldwide regulations.
• An ability to successfully communicate and educate Quality Management System regulations, policies and strategies to teams at all levels of the organization.
• Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions.
• Advanced Analytical skills; demonstrated ability to troubleshoot complex process/system issues
• Project Management and organizational change management experience, with proven success within teams and delivering on organizational objectives.
• Strong communication skills; ability to prioritize and manage multiple simultaneous programs/projects
• Strong IT Skills
• Ability to travel up to 25%

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.

How we work at Philips

Our newly adopted hybrid work concept fuses flexibility withcollaboration to deliver great outcomes for our people andour customers.We areembracing an approach wherein wespend more time together than apart - which for full-timeemployees translates to an average of at least 3 daysworking from the office and up to 2 days from home - forour hybrid roles.

Hybrid work flexibility means people can meet the changingdemands of work and home in the most balanced,productive, and healthy way.

Our hybrid working model is defined in 3 ways:

• We believe in the importance ofimpactful collaboration: There's a certain energy when everyone's in the same roomthat can heighten idea generation and creative frictionneeded for problem-solving.
• Weembrace flexibility: Choosing where, when, and how towork can vary according to task and team schedules.Flexibilityisn'toffice or online, it means choosing the spacethat works best for you, your teams, and our customers on acase-by-case basis.
• We want tobe at our best: The way wework,and ourworkspaces are designed to support our well-being, offercareer advancement opportunities, and enable us to be atour best.

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.

#LI-PH1

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