Quality management System Manager - Bangalore, India - Philips

    Philips
    Philips Bangalore, India

    3 weeks ago

    philips background
    Full time
    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.