sr Quality systems specialistMedtronic

Careers that Change Lives
Together, we will change healthcare worldwide. Join us in our Mission to alleviate pain, restore health and extend life worldwide. Let's work together to address the universal healthcare needs and improve patients' lives, optimize costs and efficiencies, and expand global access. Together, we can make a real difference in the global disparity in care. By providing quality care at the lowest possible cost, we will succeed as a company, and take the future of healthcare Further, Together.
A Day in the Life
Sr Quality Management Systems Specialist
Manage the Asia Pacific Quality Management System and its requirements, engaging with various stakeholders within the organization.
The Sr QMS Specialist will also be expected to manage Quality Management system requirements for the region.
Manage the Compliance, Supplier and Distributor requirements.
Responsible for assisting the implementation and maintenance of quality metric and monthly reports on QMS activities.
Develops employee communication and training programs that focus on the elements of a region compliance program
Responsible to assist the cultural assessment required in the region.
Ensure that the Company's agreed quality standards (including ISO13485) are maintained with regards to products, procedures, policies, operations and customer contact EAD QMS MAN
Key Responsibilities
Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
Lead cross functional project initiatives such as: system and process integrations, data migration, automation, enhancements
Support Quality Management Systems process (e.g.. Agile, Trackwise, Change Management)
Prepares reports and/or necessary documentation (e.g. Corrective and Preventative Actions, Audit reports, training compliance) and provides to applicable stakeholders, both internal and external.
Ensures the quality assurance programs and policies are maintained and modified regularly.
Facilitates uniform standards in APAC and enables best practice sharing, thereby fostering the achievement of company's mission globally.
Ensure that the Company's agreed quality standards (including ISO 13485) are maintained.
Must Have: Minimum Requirements
Bachelors degree required
Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
Your Profile
At least 5 years of quality experience in QMS in medical device industry or similar environment.
At least 5 years' experience in compliance as an auditor for medical device or similar environment.
Good understanding of ISO 13485.
Experienced as a lead auditor is an advantage.
Sound working knowledge on Agile, CAPA System is an advantage.
Bachelor's degree in Science course or Engineering/ Quality Management or related discipline.
Expérience in QMS Management, Audit & Compliance
Computer literacy including sound knowledge of the MS Office
Quality System Auditor Certification
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.
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. (ADA-United States of America)
Additional Information
Posting Date: Jul 12, 2022
Travel: No
Medtronic

Manila City, Metro Manila
Permanent
Full-time