Quality Management System Manager

Job Title

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.