QMS Manager

Job Description

nullQuality Systems Manager6 Days with rotational shifts.Your ChallengeWithin the global medical devices business managing the QMS compliance in Pune, India and providing recommendations to management and functional business units. Business sells US FDA Class II and EU MDR Class IIa&b products. Firm command of US FDA regulations, EU MDR and ISO 13485 a must. A major focus of this position will be working within a global network to communicate and address QMS challenges applicable to the US and EU.Lead the Quality Management System at Philips Pune GBS, India Ensure that the Quality Management System is created in compliance with the appropriate Philips Policies, standards and regulations required by the products supported. Take a lead role in the Quality Management Planning activity of changes to ensure compliance, outsourcing and Philips programs Provide Leadership in steering quality management systems activities with ownership of Quality Management System Management Review and creation process, Corrective/Preventive Action System, and document control and training integration. Act on required reporting to respective regulatory and notified bodies for such activities as site registrations, device licenses, changes in product types, changes in activities at the site, and changes in personnel.ResponsibilitiesJob responsibilitiesDefine and maintain the Quality Management System structure to ensure compliance to Philips Policies, ISO 9001, ISO 13485, 21 CFR 820, and EU Medical Device Regulations. Maintains, enforces, and manages a compliant and effective QMS for the activities in scope, as well as for effective and lean QMS structures and documents for Q&R processes at all levels. Establishes the Philips Quality Management System (PQMS) Framework and manages its deployment. Ensures proper audit planning and schedule meets the requirements of internal policies and external regulations. Establishes and executes a transition plan for all QMS activities in scope while maintaining compliance and effectiveness throughout the duration of the transition to the PQMS standardization. Leads/participates in the maintenance of the quality documents until such time as they are determined to be no longer applicable as part of the PQMS transition. Ensures the addition and management of any local QMS documents in line with the evolution of the QMS. Ensures training and training registration as per the QMS and generates training content for local QMS documents as necessary.Your TeamYou will report to the Head of Philips Quality Management System Integrated Supply Chain (ISC) and work in close partnership with Philips Pune Operations Quality Leader. Pune Operations Quality team consist of 25 + quality professionals involved in product quality activities for IGT, Ultrasound and MR Coils manufacturing.Our OfferGet opportunity to work in regulated Medical industry and be part of integrated supply chain Quality organization. You can support the Philips s Quality compliance culture.We Are Looking For

• Bachelor s degree in a scientific or technical field
• 5+ years of experience in the medical device industry
• Strong working knowledge of QMS, ISO 9001, ISO 13485, 21 CFR 820
• Strong understanding of Document Control, Training systems.
• Experienced manager with a minimum of 3 years of experience leading teams and delivering on organizational objectives
• Experience managing a team to deliver business application implementation projects, including experience as an active contributor on projects with scheduled deliverables.
• Experience in validating & supporting Non-product software application activities.
• Solid Analytical skills - demonstrated ability to trouble-shoot complex process/system issues.
• Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions.
• Strong IT skills, including MS Word (advanced user), Excel, Visio, and related MS Office applications.
• Proven analytical capabilities
• Excellent communication, organizational and project management skills
• Successful experience working with cross functional teams across multiple work locations
• Effective written and oral communications skills and computer skills required
• Network oriented and able to interact with different business functions and can work within numerous systems
• Work cooperatively in a team environment

In return, we offer youDescribe in two to three lines what tangible and intangible benefits the incumbent will gain in this role. Use our Employer Value Proposition (EVP) themes and information gathered in the RSM as input sources.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 improving 2.5 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.To find out more about what it s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there,you can also learn about our recruitment process, or find answers to some of the frequently asked questions.,

Keyskills :
21 cfrquality management systemaudit planningiso 9001root cause analysisms officeanalytical skillscomputer skillsclass iiproduct qualitysystem managementdocument controliso 13485quality management systems