Sr. QMS Engineer

Job Title

Job Description

Job Title : Sr. QMS Engineer

Summary:

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).

Key areas of responsibilities (KARS) for this role include:

• Ensures external and internal audit readiness and local leads for external and internal audits

• Reviews QMS and Engineering changes as well as Quality plans to ensure compliance/conformance to US FDA regulations and other Regulatory Agency and consensus standard requirements

• Ensures adequate service levels and quality for document control, records management, software validation, 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

• Owns QMS CAPAs, develops adequate and defensible root cause analyses and action plans; completes plans to schedule

• 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,; ensuring deployment of strategic projects & E2E PIL Solutions to schedule

• Promoting Q&R awareness level as determined within the organization, creates QMS transformation awareness and establishes the Philips Business System, manages all activities under the QMS governance

• Establishes an effective Management Review process, including routine reporting

• Participates in Quality & Regulatory initiatives as a cross functional contributor

• Creates QMS 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 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.

To succeed in this role, you should have the following skills and experience

•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

•Understanding and application of appropriate global medical device regulations, requirements and standards, including US 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.

•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 within India (up to 25%)

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

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.

Notice for Philips Job Seekers

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