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Job TitleSr QMS Engineer
Job Description
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, youll be working towards creating a better and fairer future for all.


In this role you have the opportunity to


Maintains a compliant, lean and effective MS/QMS. Partners across the business to continually improve and standardize PD's MS/QMS structure, documents and systems. Monitors, measures, and drives in-scope functional & process performance (both on-going and strategic).

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. You will report directly to the Sr. QMS Manager of Ultrasound.


Your role:


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
Actively assists in managing a program of Quality Plans; accountable for plan accuracy and on-schedule plan closure
Actively assists in managing Philips Intra-Company Quality Agreements.
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
Managing the QMS Document Control System, including the Philips Excellence Process Framework for the transformation the business to the Philips Business System in the Philips Integrated IT Landscape. Managing the enforcement of standardized quality systems across the Business; ensuring deployment of strategic projects & E2E PIL Solutions to schedule
Promoting Q&R awareness level as determined within the organization, Creates PQMS transformation awareness and establishes the Philips Business System, manages all activities under the PQMS governance
Establishes an effective Management Review process, including routine reporting
Participates in Quality & Regulatory initiatives as a cross functional contributor
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're the right fit if:


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

Bachelors 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
Understanding and application of appropriate global medical device regulations, requirements and standards, including FDAs 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.
Experienced Engineer with proven success within teams and delivering on organizational objectives
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 (development of project plans, status meetings, project reporting, etc.) and organizational change management
Strong communication skills; ability to prioritize and manage multiple simultaneous programs/projects
Strong IT Skills
Ability to travel up to 25%



About Philips


We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

Learn more about our business.
Discover our rich and exciting history.
Learn more about our purpose.
Read more about our employee benefits.

If youre interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.


Philips Transparency Details


The pay range for this position is $74,000 to $136,000, Annually. The actual base pay offered may vary depending on multiple factors including, job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.


Additional Information

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
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Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.