Quality Systems Specialist

4 days ago

Taguig, National Capital Region, Philippines Medtronic Full time

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

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

This role will support the FCA Center Led Global Region organization with day-to-day support.

Responsibilities may include the following and other duties may be assigned:

  • Review and file submitted evidence for Field Corrective Actions.
  • Accurately log information received through the forms in the trackers and ensure they are up to date.
  • Monitor the progress, perform timely follow-up, drive the completion of ongoing FCA activities, and flag activities at risk of missing the deadline.
  • Investigate issues preventing completion of FCA actions and work with the Senior Quality System Specialist to identify solutions.
  • Responsible for meeting the KPI for the assigned FCAs and set up RecallNet campaigns.
  • Responsible to prepare and distribute/submit reports on time (e.g. monthly, QBR, QMR, TGA and Medsafe progress reports).
  • Attend to country requests for data needed for (e.g. tenders, registration application or renewal, distributor performance, QMR / QBR).
  • Prepare and support audits by acting as the auditee.
  • Analyze and identify data discrepancies or inconsistencies, and analyze trends and opportunities for process improvement.
  • Participate in the periodic review of procedures, work instructions, and other QMS documents.
  • Other duties as assigned by the supervisor or manager and complete assigned trainings on time.
  • Uphold patient safety and regulatory compliance and observe all health and safety policies and procedures, taking all reasonable care that actions or omissions do not impact the health and safety of others.

Required Knowledge and Experience:

  • Bachelor's Degree Required in Medical/Biological Science/Engineering or related discipline.
  • At least 3-4 years of quality experience in the medical device industry or similar environment.
  • Preferably with experience in managing/handling FCA or PMV activities.
  • Good understanding of GDP and its implementation is required. Knowledge of ISO 13485 and its implementation will be an added advantage.
  • Working knowledge in advanced Excel or SmartSheet application is a must.
  • Computer literacy including sound knowledge of the MS Office Suite or software.

Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package.
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves, and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here.

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