Sr Quality Systems Specialist
Careers That Change Lives
In this exciting role as a Senior Quality Systems Specialist, you will have responsibility for managing assigned projects and working with other stakeholders to achieve desired results within the quality systems.
The Cranial and Spinal Technologies Organization develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.
Within CST this role will support the Enabling Technologies, delivering an innovative portfolio that includes advanced imaging, navigation, robotics, customized implants, and pre-operative planning aided by artificial intelligence
A Day in the Life
Responsibilities include the following and other duties may be assigned.
- Provides oversight for the development and maintenance of quality programs systems, processes with policies and that the performance and quality of services conform to established and guidelines.
- Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulatory compliance.
- Creates and maintains metrics and reporting for promotional labeling process.
- 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 proactive sharing, thereby fostering the achievement of company’s mission globally.
Other duties may be assigned
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Bachelor’s Degree with 4+ years of work experience in Quality and/or experience in a regulated industry OR Advanced Degree with 2+ years of work experience in Quality and/or experience in a regulated industry
Nice to Have (Preferred Qualifications)
- Audit – Quality and Compliance Experience
- Corrective and Preventative Action (CAPA)
- Quality Management System Experience
- Quality System Regulation Experience
Additional exposure may include the following:
- AAMI – The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485
- Think Reliability – Cause Mapping
- Lean Sigma Trainings
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)
