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:
This role will support FCA Center Led Global Region organization with day-to-day support. Will act as support for stakeholders involved in FCA activities and act as the Field Corrective action conciliator. This role will work closely with the local quality agents and Commercial areas for the execution of FCA in country.
Ensure personal understanding of all quality policy/system items that are personally applicable. Follow all work/quality procedures to ensure quality system compliance and high-quality work.
Manage customer notification translations according and execute consolidation of actions evidence
Ensuring alignment with QA SSC FCA specialist about actions to be done with the stakeholders responsible for FCA execution.
Closely monitor the accuracy, the quality and the timelines related to recall data entry and effectiveness checks reporting to senior and corporate management.
Maintain all FCA documentation in the quality repository.
Be a change agent for the organization. Identify, facilitate, and implement changes to improve efficiency, compliance and reduce complexity of processes as required.
Operate within compliant quality system environments and participate/support Quality System Audits in in the regions supported.
Foster cross-functional partnerships and mutual understanding of recalls and field corrective actions.
Must Have:
Bachelor's Degree Required in Medical, Biological Science, Pharmaceutical Science, Engineering, or any related discipline
Min 0 year of experience required
Your Profile
Proficient in speaking, reading and writing Portuguese or Italian
Foreign talents holding Permanent Resident visa will be highly preferred
Good understanding international regulations for Medical Devices and Drugs regarding PMV/Mandatory Medical Devices Problem Reporting, Adverse Events reporting and Recalls (basic understanding of international regulations).
Previous experience supporting quality system audits.
Strong technical writing and documentation review skills.
Influence management skills: ability to work constructively across all functions of the organization and build relationships.
Experience writing and reviewing of technical documentation.
About Medtronic
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.
