Senior Quality Assurance Specialist
Careers That Change Lives
Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Being a 'trusted partner' means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs.
A Day in the Life
The Senior Compliance Specialist is responsible for the planning and re-planning of Field Corrective Actions by coordinating with various stakeholders globally.
This position involves coordination with a diverse group of people in the following global areas: Legal, Sr. Quality Leadership, Reliability Engineers, Supply Chain and Marketing, as well as several others. This role requires collaboration with stakeholders globally and requires attending and facilitating meetings that accommodate all time zones globally.
Responsibilities may include the following and other duties may be assigned.
- Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
- Prepares reports and/or necessary documentation for field corrective actions and provides to applicable stakeholders, both internal and external.
- Co-ordinates legal requests in support of government investigations or litigations.
- Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
Must Haves
- Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A)
- Minimum of 3 years of relevant experience, or advanced degree with 0 years of experience.
Your Profile:
- Experience developing effective written communications and executive presentations.
- Project management experience with ability to manage multiple projects simultaneously.
- Experience participating in product recalls/field corrective actions
- Experience in customer service, supply chain, or contracts
- Experience with FDA regulatory medical device requirements, 21CFR Part 806, Part 7; ISO 13485, Medical Device Directive.
- Excellent written and verbal communication abilities.
- Experience with Good Documentation Practices
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.
