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.