Associate Quality Systems Specialist - #116466

Medtronic


Date: 2 weeks ago
City: Taguig, Metro Manila
Contract type: Full time

Careers that Change Lives


Bold thinking. Bolder actions. We are Medtronic.

Quality Assurance & Regulatory Affairs Shared Service Center team aims to be a strategic and trusted partner in Asia Pacific Region. Providing value-add services, drive reengineering of process, resource optimization and cost savings, we aspire excellence to drive solutions for centralized processes, integrate these values into what we do therefore enabling our stakeholders to achieve their goals with a balance of quality, productivity, cost, and effective service.


A Day in the Life


The Quality Systems Specialist will support Asia Pacific Region Post Market Vigilance activities related to Product Complaint Handling. The successful candidate(s) will be responsible for the Vigilance processes in India to be transitioned by country QARA to the Center-led Complaint Handling team for efficiency and centralization.

  • Maintain stability and efficiency of transitioned activities (RD/RR) with an intention to improve and refine the process.
  • Improve Vigilance timeliness performance during and after the transfer of RD and RR activities from local country RA to the Center-led Complaint Handling team.
  • Ensure PMV are executed as defined in applicable quality documents.
  • Responsible for assisting the Sr. Quality Specialist on the execution, monitoring, and closure of Complaints throughout the Global Regions.
  • Responsible for the implementation and maintenance of quality metric and monthly reports on PMV activities.
  • Prepare reports, analyze data to identify trends and opportunities for improvement related to the
  • Draft comprehensive regulatory reports for necessary product events.
  • Escalate high risk incidents to management and PMV team.
  • Observe all health and safety policies and procedures and take all reasonable care that actions or omissions do not impact on the health and safety of others.


Must Have

Bachelor's Degree Required in Medical, Biological Science, Pharmaceutical Science, Engineering, or any related discipline


    Your Profile

    • With minimum of 1 to 2 years of experience in Post Market Surveillance, Vigilance or QA/RA role.
    • Good understanding of GDP and its implementation is required. Knowledge of ISO 13485 and its implementation will be an added advantage
    • Complaint handling experience is an advantage.
    • Knowledge in regulatory requirements for adverse event reporting for approved devices (FDA, TGA, MedSafe, HAS etc,) is a great advantage.
    • Computer literacy including sound knowledge of the MS Office Suite or software


    About Medtronic


    Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.


    What We Offer


    We recognize the personal worth of employees by providing an employment framework that allows personal satisfaction in work accomplished, security, advancement opportunity, and means to share in the company's success. We believe in rewarding our staff with a complete package of benefits designed to support them at every career and life stage. As a result, our employees have access to the following benefits, to name a few:

    • Our global well-being program supports your physical, emotional, social and financial well-being.
    • Medtronic Employee Assistance Program offers confidential support and resources to build and enhance employee and organizational resilience, productivity, teamwork and psychologically healthy workplaces.
    • Various insurance benefits include Inpatient and Outpatient Medical Insurance, Life, Disability and Accident Insurance.
    • We have generous employee referral programs, employees stock purchase plan, leave benefits, and more!


    Physical Job Requirements


    The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

    How to apply

    To apply for this job you need to authorize on our website. If you don't have an account yet, please register.

    Post a resume

    Similar jobs

    Team Lead, Cloud Operations

    NICE, Taguig, Metro Manila
    1 day ago
    At NICE, we don't limit our challenges. We challenge our limits. Constantly. We're relentless. We're ambitious. And we make an impact. Our NICErs bring their A game and spend each day turning it into an A+. And if you're like us, we can offer you the kind of challenge that will light a fire within you. Manages the planning, hardware...

    Finance & Accounting Services Intern

    DB Schenker, Taguig, Metro Manila
    1 day ago
    At DB Schenker, you are part of a global logistics network that connects the world. A network that allows you to shape your career by encouraging you to contribute and truly make a difference. With more than 76,000 colleagues worldwide, we welcome diversity and thrive on individual backgrounds, perspectives and skills. Together as one team, we are Here to move....

    Credit & Collections Specialist - Global Business Services

    Abbott, Taguig, Metro Manila
    2 days ago
    JOB DESCRIPTION:At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are...