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Job TitleQuality management System Manager
Job Description
Business title
: Quality management System Manager
Location
: Bangalore
KEY AREAS OF RESPONSIBILITIES:
Ensures compliant and effective QMS's are maintained in scope.
Accountable for the transformation of all current QMS's parts in scope towards the single PQMS structure.
Accountable to manage and harmonize all QMS management processes and ensure the FDA-compliant validation of all SW systems in scope.
Manages (local) Q&R processes and ensures (local) process ownership for all activities under the PQMS governance in scope.
Ensures Q&R requirements are effective in all processes in scope.
Ensures Document Control is established and ensures training profiles are assigned and enforced and training administration is established within scope.
QMS Manager responsibility
Administers a compliant and effective QMS for the activities in scope.
Enables the transition/deployment of the PQMS (Philips quality management system) and manages its deployment.
Ensures proper audit planning and schedule meets the requirements of internal policies and external regulations.
Locally manages plans for all QMS parts in scope while maintaining a compliant and effective (local) QMS throughout the duration of the transition to the PQMS - Philips quality management system.
Administers and contributes to the management of any local QMS documents in line with the evolution of the PQMS -Philips quality management system.
Process definition compliant to standards and regulations.
Modernizing QMS for business fit and efficiencies.
Expert in requirements of FDA, EUMDR and health care standards
Supports training and training administration as per the QMS and contributes to training content for local QMS documents as necessary.
Contributes to the availability of metrics/KPI data to measure training effectiveness, PQMS (Philips quality management system) deployment and QMS Compliance.
Works on issues where analysis of situation or data requires review of relevant factors.
Exercise judgement within defined procedures and policies to determine appropriate action.
Acts as advisor to unit or sub-units and may become actively involved as required to meet schedules and resolve problems.
Education
Bachelor's degree in engineering - IT software, electronic, biomedical engineering.
Experience & Background
Minimum 12 years of work experience and min 8 years in quality management system.
Experience working in disciplined regulated healthcare industry.
Experience with business application implementation projects, including experience as an active contributor on projects and scheduled deliverables.
Philips
