What are the responsibilities and job description for the Quality Systems Specialist position at Medtronic?
Careers that Change Lives
Main Purpose:
Responsible for establishment & implementation of robust Operations Quality compliance systems in Medtronic. Also responsible for ensuring that effective Quality Assurance systems, programs and processes are in place.
Job Responsibilities
- Responsible for implementation, handling and addressing routine Quality compliance systems and processes related to Quality Management System (QMS), Change & Risk Management, Supplier Management, Reports Preparation, Training and provide inputs towards their effective resolution in collaboration with relevant counterparts.
- Track and Trend Quality Change Order’s impacting Indian including various stakeholders (EOC, SBU’s, employees, distributors, customers, etc.) and coordinate with counterparts/stakeholders for successful implementation.
- Execute Supplier Management process as per defined categories & requirements. Monitor & maintain the performance of supplier to ensure the quality compliance as per Medtronic standards.
- Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
- Monitor performance and health of QMS & supplier management processes to mitigate risk.
- Execute policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
- Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
- Effective control of documents by proper distribution and archival in database.
Must Have- Minimum Requirements
- Must have at least 4-7 years relevant Quality Management System (QMS), Change & Risk Management, Supplier Management Quality experience in the pharma/medical device/life science industry.
- Experience in Quality systems implementation and maintenance; GMP/Quality Systems Regulations; ISO 13485 is a plus.
- Knowledge and competency in application of FDA, ISO 13485 and other regulatory requirements especially in the area of Quality Systems is a plus.
Attributes:
- Easily communicate with colleagues, management and external authorities
- Be able to plan, manage, organize and report in an efficient way
- Be independent, persuasive, innovative and able to summarize
PHYSICAL 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. 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.
ABOUT MEDTRONIC
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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 can 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.
