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Philips Sr QMS Engineer India, Karnataka 602526736
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Job Description
Job Title : Sr. QMS Engineer
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
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%)
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:
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