Associate Quality Systems Specialist

1-2 years
16 days ago
Job Description

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

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.

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