Philips Senior Manager - QMS in Pune, India

Roles & Responsibilities :

  • Establish and maintains the Quality Management System policies, processes and procedures to ensure compliance with the applicable domestic and international regulations as well as Philips Healthcare corporate policies.

  • Manage the internal audit program within the DMC India as well as coordinate audit schedules with the Corporate Compliance group

  • Prepares Management Review meeting for DMC India

  • Lead HIC India sites in the preparation for and during external and internal audits as well as providing support for the development of responses to those audits.

  • Plans and executes the Business-Audit Year Program in cooperation with various departments.

  • Provide quality compliance consultation and mentoring to HIC India personnel

  • Assist and/or lead in HIC India compliance remediation projects and process development/improvement initiatives whenever needed.

  • Lead the delivery of quality training programs

  • Support Management reviews per HIC India procedure, working with management representative.

  • Execute NPI / design transfer and Industrial transfer to manufacturing site in compliant way.

Technical/Functional Competencies :

  • 10 to 15 Years of experience (medical device industry experience preferred).

  • Demonstrated compliance fluency as per ISO Regulations (ISO13485/ USFDA QSR)

  • Demonstrated auditing and corrective action proficiency.

  • Superior knowledge/application of all Quality System elements.

  • Demonstrated record of successfully assessing and determining the impact of current and potential regulatory compliance issues.

  • Demonstrated record of successful project management, process development, and process improvement..

  • Superior communication and mentoring skills, ability to build consensus at all levels.

  • Demonstrated ability to identify and develop high potential personnel

  • Demonstrated quality training delivery experience.

  • NPI and design transfer experience will be an added advantage.

Behavioral Competencies :

  • Fluent in oral and written English , Good technical writing skills

  • Good and mature communication skills,

  • Ability to train people on new subjects, convincing personality

  • Good team player and able to influence cross functions.