Job Title

Job Description

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

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.

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:

The Senior Quality Management Systems (QMS) Engineer will play a critical role in ensuring Quality Systems compliance for Philips Sleep & Respiratory Care products, improving, and saving lives around the world.

You are responsible for:

• Ensures external and internal audit readiness and provides support during external and internal audits.
• Supports certification relationship with Notified Body as appropriate.
• 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
• Establishes an effective Management Review process, including routine reporting.
• 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.

You are a part of:

A Quality team of QMS Engineers focused on the compliance and transformation of the Sleep and Respiratory Care quality system. Philips Sleep and Respiratory Care drives integrated therapy solutions in the hospital and home environments, with a goal of improving diagnosis, treatment, and patient enablement across the healthcare spectrum. Our mission is to improve the quality of life for consumers and patients through better awareness, diagnosis, treatment, monitoring, and management of their conditions.

To succeed in this role, you’ll need a customer-first attitude and the following:

• Minimum of a Bachelor’s degree in an Engineering, Quality, Regulatory or Scientific discipline.
• Minimum of 7+ years’ experience in the FDA regulated Medical Device or HealthTech industry.
• Proven experience in the application of automated technology, particularly GAMP 5 preferred.
• Understanding and application of appropriate global medical device regulations, requirements, and standards, including FDA’s 21 CFR 820, ISO 13485, EU Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, ANVISA, ISO 14971, ISO 9001, and others including 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.
• Strong communication skills.
• Ability to prioritize and manage multiple simultaneous programs/projects.
• Ability to travel up to 25% (travel mainly to other Sleep & Respiratory Care sites in the Pittsburgh area- Murrysville, New Kensington, Mt Pleasant.
• US work authorization is a precondition of employment. The company will NOT consider candidates who require sponsorship for a work-authorized visa.

In return, we offer you:

A path towards your most rewarding career. Philips is growing its 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.

How we work at Philips
Our newly adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles.
Hybrid work flexibility means people can meet the changing demands 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 of impactful collaboration: There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.
We embrace flexibility: Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.
We want to be at our best: The way we work, and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.

Why should you join Philips?

Philips is a global leader in health technology, committed to improving 2.5 billion of lives worldwide and striving to make the world healthier and more sustainable through meaningful innovation. Driven by the vision of a better tomorrow. But it’s not just what we do, it’s who we are. We are 75,000, 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.

#LI-PH1

Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.