What are the responsibilities and job description for the Assoc Quality Systems Spec position at Medtronic?
The Operations Quality Compliance department at Medtronic's North Haven, CT site plays a crucial role in ensuring the highest standards of quality and regulatory compliance for our endo-mechanical devices and suture products. Our team is dedicated to maintaining compliance with regulatory standards and company procedures, optimizing our quality management system, managing configuration assurance, management of external and internal audits, managing and executing the learning management system(LMS), monitoring key performance indicators (KPIs) related to quality, managing the Corrective and Preventive Actions (CAPA) system, supporting the digitization of our quality processes and driving continuous improvement initiatives within the QMS.
Our team culture is one where every individual is expected to “Lead from Every Seat.” Regardless of level or title, everyone is encouraged to be bold, curious, accountable, proactively tackle challenges, and bring forward meaningful solutions.
Join a diverse team of innovators who bring their world view, their unique backgrounds, and their individual life experiences to work every day.
Medtronic is intensely focused on creating a workplace environment which reflects our standing as the world’s top medical device company. The ideal candidate will have a passion for the patients we serve and an unrelenting desire to improve our business.
We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.
To learn more about Inclusion & Diversity at Medtronic Click Here
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
- 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.
- Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
- Co-ordinates legal requests in support of government investigations or litigations.
- 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.
- Bachelors degree required
- 0 years of experience required
Nice to Have
- System integration and data presentation experience, primarily via PBI.
- Demonstrated track record of being able to effectively manage projects.
- Medical device industry exposure
- Critical and creative thinking
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, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here.
This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here.
The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.
