Quality Systems Specialist
Careers That Change Lives
A career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide.
In this exciting role as a Quality Systems Specialist you will support the Internal Supplier Controls Centre of Excellence as part of the Global Supplier Quality Team. You will join a dynamic team responsible for driving excellence in Internal Supplier Management across the Enterprise.
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
- Provides oversight for the execution of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of internal suppliers 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.
- Prepares reports and/or necessary documentation and provides to applicable stakeholders, both internal and external.
- Ensures the quality assurance programs and policies are maintained and modified regularly.
- Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
- Supports key elements of the Global Supplier Quality Strategy focused on Internal Suppliers including creation and maintenance of Internal Quality Agreements and performance monitoring
- Collaborate and review QMS changes to ensure compliance with internal and external requirements maintained.
- Works with cross functional operational team representatives on internal supplier control projects.
- Travel requirement:
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Bachelor's degree with 2+ years of work experience in Quality or regulated industry OR Advanced degree with 0+ years of work experience in Quality or regulated industry.
Nice to Have
- Experience with Agile MAP, specifically ASL functionality
- Proficient with MS PowerPoint
- Technical Writing Experience/Training
- Supplier Quality Engineering experience
- Cross-functional knowledge and/or experience.
- Strong critical thinking and analytical skills with the ability to define problems, collect data, establish facts, and draw valid conclusions.
- Excellent communication (oral and written), presentation and interpersonal skills.
- Influence management skills; ability to work cooperatively and across all functions of the organization.
- Demonstrates initiative; results oriented.
- Effective decision-making skills - ability to negotiate and balance decisions and priorities across needs of several functional departments.
- Makes timely decisions in the face of risk and uncertainty.
- Experience with quality tools and process improvement techniques
- Medical Device Experience
- Understanding of 21 CFR 820 and ISO 13485
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)
