Senior Clinical Quality Specialist, Corporate Clinical Quality & Compliance (CCQC)

Bachelor’s degree and minimum of 4 years of clinical research and/or quality with audit/compliance/CAPA experience within the healthcare industry or advanced degree with a minimum of 2 years clinical research and/or quality with audit/compliance/CAPA experience within the healthcare industry 

Nice to Have (Preferred Qualifications):

• Experience working with the clinical study lifecycle (e.g., planning, execution and closeout)
• Experience with Good Clinical Practices (GCP)
• Experience with FDA and international regulations (pharmaceutical and/or device, e.g., 21 CFR 812, 50, 54, 56, 820, ISO 13485, ISO 14155) and/or experience in Quality System regulations.
• Experience with Corrective and Preventive Action (CAPA)
• Experience working on audits/compliance within clinical/quality/regulatory
• Knowledge of 21 CFR 803, 806, ISO 14971
• Experience in clinical quality assurance at Medtronic or within a medical device industry.
• Experience in project/program management and/or continuous improvements to processes and procedures.

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 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 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)

Ability to travel up to 25%.

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 at benefits.medtronic.com