Associate Quality System Specialist(BGC Taguig) 6 months project

2 weeks ago

Manila, National Capital Region, Philippines Business Trends Philippines Full time

Job Dimension:

Support Asia Pacific Region Post Market Vigilance activities related to Product Complaint Handling

Main Purpose:

Ensure PMV are executed as defined in applicable quality documents.Responsible for assisting Quality Specialist on the execution, monitoring and closing of Complaints throughout APAC regions. Coordinate the product returns from customer to BU for all PER with product return request.Responsible for assisting the implementation and maintenance of quality metric and monthly reports on PMV activities. Ensure that the Company's agreed quality standards (including ISO13485) are maintained with regards to products, procedures, policies, operations and customer contact

Key Accountabilities:

Support implementation and compliance to the company's Quality Management System. Support establishment of quality specifications and standards and support the development of processes and standardsFacilitate update of quality documentation, process mapping, reviewing processes and assisting with change initiativesObserve 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.Work within and actively promote Medtronic's Mission, corporate strategies, policies, procedures and Code of Conduct.Actively communicate and collaborate with PMV team and stakeholders related to complaints processPrepare reports, analyze data to identify trends and opportunities for improvement related to the processManage, update and track activities related to Complaint/Product Returns timely and accuratelyDemonstrated initiative through problem-solving and system thinking.Effective verbal and written communication and interpersonal skills.Ability to perform work with minimal supervision.Other duties as assigned by the supervisor/managerResponsible, professional, detail-oriented and has patienceAptitude for technologyWell organized, quick thinker, and creativeResponse to deadlines and prioritiesResilient, persistentAttributes:

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.Demonstrated initiative through 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.Effective verbal and written communication and interpersonal skills.Ability to perform work with minimal supervision.Experience and Knowledge:

At least 2 years (Assoc) or 3-4 years (Specialist) of quality experience in medical device industry or similar environmentGood understanding of GDP and its implementation is required. Knowledge of ISO 13485 and its implementation will be an added advantageComplaint handling experience is an advantage. Qualifications: Bachelor's Degree Required in Medical/ biological science/ Engineering or related disciplineWith to 1 year (Assoc) or 2 years (Specialist) of relevant experience in Post Market Surveillance or QA RoleComputer literacy including sound knowledge of the MS Office Suite or softwareProven evidence of Medtronic Traits:Mission Values: Consciously works to bring the Mission aliveExternal Focus: Customer responsive, competitive and market driven, leads and supports ChangeClear Thinking: Translates complexity into simplicity, articulates crisply and clearlyDriven to Win: Passionate and driven, makes tough decisions in difficult situationsInspires Others: Authentic and sets a vision to inspire performance and engage othersExecutes: Takes accountability for and consistently delivers consistent decisions, actions, and resultsBoundaryless: Breaks down silos, collaborates across organizational boundariesGlobal: Culturally agile, strives to understand diverse market needs and responds with creative and effective solutionsIntegrity and Compliance: Practice the highest ethical standards and integrity in every aspect of my job.

  1. Working Time : 7:00am- 4:00pm
  2. Working Days: 5
  3. Work set up? Onsite, WFH or Hybrid? Hybrid
  4. Required [background in QA is preferred.

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