Associate Quality Systems Specialist

2 weeks ago

Taguig, National Capital Region, Philippines Medtronic Full time
Medtronic Associate Quality Systems Specialist in Taguig City, Philippines

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 Associate 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.

You will be responsible for performing administration processing of transactions, data input and verification of required documentation, identifying, navigating, researching and troubleshooting HR transactional processes related to employee life cycle processes. 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

  1. At least 2 years of quality experience in the medical device industry or similar environment is an advantage.
  2. Good understanding of GDP and its implementation is required.
  3. Sound awareness and knowledge of ISO 13485 and its implementation.
  4. Complaint handling and Post Market Vigilance experience is an advantage.
  5. Strong experience and knowledge in regulatory requirements for adverse event reporting for approved devices (TGA, MedSafe, etc.) is a great advantage.
  6. Experience in writing comprehensive regulatory reports is an advantage.

Nice to Haves

  1. Demonstrated ability to communicate professionally, both written and orally, to a wide variety of audiences.
  2. Skilled in influencing and partnering with others, both inside and outside of Quality.
  3. Detail-oriented, Responsible, and Patient.
  4. Agile Learner and Adaptable.
  5. Proactive in problem-solving and system thinking.
  6. Good understanding of post-market vigilance and complaint handling practices.
  7. Self-starter and accountable, with sharp focus on quality and customer experience.
  8. Excellent verbal and written communication skills.
  9. Outgoing and friendly, willing to assist others.
  10. Can work either autonomously or in a team.
  11. Aptitude for technology.
  12. Well organized, quick thinker, and creative.
  13. Strong time management skills & good in task prioritization.

We Offer

We offer a competitive salary and benefits package to all our employees, including a flexible working environment, an Annual Incentive Plan % depending on company results, a pension scheme, group discount on healthcare insurance, training possibilities via Cornerstone/Skills Lab, and an Employee Assistance 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.

Your Answer

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

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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, and they share in the success they help to create.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law.

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