Quality management System Manager
Location
Bangalore | India
Job description
JOB DESCRIPTION
Job Title
Quality 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.
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