Associate Quality Systems Specialist

1 week ago

Taguig, National Capital Region, Philippines Medtronic Full time

Associate Quality Systems Specialist page is loaded

Associate Quality Systems Specialist

Apply remote type Hybrid locations Taguig City, National Capital Region, Philippines time type Full time posted on Posted Yesterday job requisition id R23273

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

Associate Quality Systems Specialist for ANZ new Vigilance process (Reportability Decisions, Regulatory Reporting and Regulatory Inquiries).

Careers that Change Lives

At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress and deliver meaningful innovations.

The Quality Systems Specialist will support Post Market Vigilance activities related to Product Complaint Handling under the organization of the Center-led Post Market Vigilance team for Complaint Handling.

The successful candidate(s) will be pioneering the new Vigilance process for Australia wherein he/she will be involved in the drafting and submission of regulatory reports to the Australian regulatory agency, working closely with the Australian local QARA team in fulfilling these activities. Other responsibilities include Vigilance activities for New Zealand. The candidate will also be provided opportunities for knowledge and exposure to other Vigilance processes in the Medtronic Global Regions.

Your Responsibilities
  • Perform daily operations whilst adhering precisely to the defined Work instructions & FAQs for your ELC Team providing answers to customers on a range of topics from HR policies, Payroll, Benefits and many more.
  • Ensure vigilance activities stipulated in the relevant QMS document(s) for Australia and New Zealand and other regions/countries (if necessary) are executed accordingly and accurately.
  • Maintain stability and efficiency of Vigilance activities with the objective to improve and refine the process.
  • Ensure that Service Level Agreement between the local QARA team and the Center-led PMV organization are met.
  • Be accountable for relevant PMV KPIs.
  • Support/assist the Sr. Quality Specialist on the execution, monitoring, and closure of assigned vigilance tasks.
  • Responsible for the implementation and maintenance of quality metrics and monthly reports for PMV activities.
  • Ensure that the Company's agreed quality standards (including ISO13485) are maintained with regards to products, procedures, policies, operations, and customer contact.
Must Haves
  • At least 2 years of quality experience in the medical device industry or similar environment is an advantage.
  • Good understanding of GDP and its implementation is required.
  • Sound awareness and knowledge of ISO 13485 and its implementation.
  • Complaint handling and Post Market Vigilance experience is an advantage.
  • Strong experience and knowledge in regulatory requirements for adverse event reporting for approved devices (TGA, MedSafe, etc,) is a great advantage.
  • Experience in writing comprehensive regulatory reports is an advantage.
Nice to Haves
  • Demonstrated ability to communicate professionally, both written and orally, to a wide variety of audiences.
  • Skilled in influencing and partnering with others, both inside and outside of Quality.
  • Detail-oriented, Responsible, and Patient.
  • Agile Learner and Adaptable.
  • Proactive in problem-solving and system thinking.
  • Good understanding of post market vigilance and complaint handling practices.
  • Self-starter and accountable, with sharp focus on quality and customer experience.
  • Excellent verbal and written communication skills.
  • Outgoing and friendly, willing to assist others.
  • Can work either autonomously or in a team.
  • Aptitude for technology.
  • Well organized, quick thinker, and creative.
  • Strong time management skills & good in task prioritization.
We Offer

We offer a competitive salary and benefits package to all our employees:

  • Flexible working environment.
  • Annual Incentive Plan % depending on company results.
  • Pension scheme and group discount on healthcare insurance.
  • Training possibilities via Cornerstone/Skills Lab.
  • Employee Assistance Program and Recognize (our global recognition program).
Our Commitment

Our unwavering commitment to inclusion, diversity, and equity (ID&E) means zero barriers to opportunity within Medtronic and a culture where all employees belong, are respected, and feel valued for who they are and the life experiences they contribute.

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 90,000+ passionate people. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day.

In everything we do, we are engineering the extraordinary.

Your Answer

Is this the position you were waiting for? Then please apply directly via the apply button

#LI-Hybrid

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.

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