Quality Systems Specialist

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 and/or experience in a regulated industry OR Advanced Degree Engineering, Science or technical field with 0+ years of work experience in Quality and/or experience in a regulated industry.

• Understanding of FDA’s Quality System Regulation and ISO 13485 requirements for quality management systems, including supporting CAPA investigations or similar activities in other regulated environments.
• Experience with document control, process improvement and project management, database administration processes, or similar activities, in a regulated or highly structured environment (e.g., medical device, aerospace, automotive, military)
• Familiarity with modern ERP systems, PLM systems, manufacturing and Quality System documentation (i.e., parts, BOMs, item masters, SOP, WI)
• Ability to communicate in writing clearly and concisely
• Highly capable of attention to detail and accuracy
• Ability to work in a team environment
• Strong time management, organizational, and prioritization skills
• Ability to effectively manage multiple projects and priorities, with a high degree of initiative and good judgment.
• Ability to interface professionally at all levels of the organization.

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 above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

The physical demands described within the Day in the Life 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.

Travel must be domestic and international up to 25%