Quality Systems Specialist
Careers that Change Lives
Written in 1960, our Mission dictates that our first and foremost priority is to contribute to human welfare. Over a half-century later, the Mission continues to serve as our ethical framework and inspirational goal for our employees around the world.
A Day in The Life
Part of the Quality Management Systems function, you will be the Specialist for our Corrective and Preventive Action (CAPA) workstream, supporting Classic CAPA, Fast Track CAPA, and Correction Only activities across the Asia Pacific region.
- Work hand in hand with operating groups to provide monitoring of activities within the Corrective and Preventive Action process: (1) analysis and identification of root cause (2) analysis of the impact of the quality problem (3) definition of corrective and preventive actions that remedy the root cause (4) and the definition of effectiveness.
- As a Process Owner or Document Owner, ensure that all activities are aligned with Quality System Management (QMS) guidelines. Manage and prepare documentation about KPI reports and share with relevant stakeholders such as the CAPA Board.
- Ensure that all the evidence of activities carried out in the Fast Track CAPA and Correction Only process complies with good documentation practices and is reflected in the Trackwise system on time.
- Participate in the creation, execution, and review of process improvement plans for the Fast track CAPA and Correction Only processes
- Participate and support Quality Management System Audits in the Asia Pacific region
- Support Quality Management System activities of the Customer Care Operations Team when required: Quality Leads Meetings, Training tickets management, Knowledge Management approvals, etc.
- Provide back up for the Senior CAPA Specialist when required
Must Have: Minimum Requirements
- Bachelor’s Degree is required
- Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience
Your Profile
- Bachelor’s Degree in Life Science, Engineering or related degree (i.e. Pharmacy, Biomedical Engineering)
- Minimum 2 years of relevant experience in Quality Management Systems
- Knowledge on Corrective and Preventive Action process is an advantage
- Experience in technical writing and documentation is an advantage
- Experience working with a highly regulated industry (medical devices, pharmaceuticals, etc) is preferred
- Self-starter, and can work independently with the available relevant information, alternatives, knowledge of regulations, etc.
- Able to build relationships across all functions of the organization
About Medtronic Philippines
Established in 2015, Medtronic Philippines is committed to best-in-class patient and customer experience by delivering capacity, scalability, sustainable productivity levels and innovative solutions to our stakeholders, patients and customers.
The establishment has over 450 employees on-site with more than 60% being female employees
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.
