We anticipate the application window for this opening will close on - 9 Apr 2025

 

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

In this exciting role as a Senior Compliance/Audit Specialist, you will be responsible for ensuring compliance with regulatory requirements and internal policies at Medtronic’s North Haven, CT, manufacturing site. You will play a key role in maintaining quality and regulatory standards by facilitating and preparing for audits, assessing risks, and driving continuous improvement initiatives within the Quality Management System.



Written in 1960, Medtronic's Mission dictates that our first and foremost priority is to contribute to human welfare. Over a half-century later, the Mission continues to serve as our ethical framework and inspirational goal for our employees around the world.



The North Haven Site is part of the Medical Surgical Portfolio of Medtronic, specifically Surgical Innovations. In Surgical Innovations, we advance minimally invasive surgery to improve outcomes for patients and providers around the globe. From concept to commercialization, we bring meaningful innovation to our robust and growing portfolio of surgical devices and technologies. Through wise investments, thoughtful planning, and world-class partnerships, we help patients get the care they need – from diagnosis to treatment – when they need it.



This position is based at the North Haven, CT site with flexible work arrangements as needed.

Responsibilities may include the following and other duties may be assigned.

• Coordinates and/or completes internal/external risk assessments and/or audits and compliance in accordance with regulatory standards, which may include US and/or international regulatory agencies / authorities.
• Manages and oversees internal audit activities, which may include conducting and/or overseeing audits, investigations, and/or interviews; and preparing corresponding reports and documents.
• Interprets and implements applicable regulations as they apply to products, processes, practices and procedures.
• May counsel stakeholders about these requirements as necessary.
• Ensures compliance with internal and external regulatory agencies, which may include investigating and resolving compliance violations, questions, or concerns.
• Analyzes audit data and presents findings to management and/or regulatory bodies in support of Corrective Action Plans, which may include coaching business partners on compliance gaps, data, and/or resulting corrective actions.
• Develops and implements programs, communications, and/or training designed to increase employee awareness and knowledge of compliance policies and/or processes.

Required Knowledge and Experience: 
Requires a Baccalaureate degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Preferred Qualifications:

• Expertise in ISO 13485 and CFR 820 regulations.  

• Experience leading and executing FDA inspections and TUV audits. 

• Expertise/Familiarity with CAPA. 

• PBI Dashboard creation experience 

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.

Benefits & Compensation
 

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their c