Internal Auditor Corporate Quality

Getinge•Nashua, NH

2d•$85,000 - $100,000•Remote

About The Position

The Corporate Quality Internal Auditor will perform Global Internal Audits to improve compliance throughout Getinge sites, providing early warning of noncompliance and other regulatory requirements. They will be responsible for conducting audits, as required, and completing the associated documentation in a timely manner.

Requirements

Bachelor’s Degree (BA/BS) or equivalent, preferably in a life science or related discipline, or an equivalent combination of education and experience
Minimum 3 years’ experience in Quality System Audit
Proven experience in completing and maintaining audit documentation
Proficient using MS Office applications
Working knowledge of all elements of a Quality System, in particular Internal Audit, Corrective, and Preventive Action Subsystems.
Education and Experience to understand and comply with U.S. and Worldwide medical device regulations.
Evidence of training to QSmR, ISO 13485:2016, EU MDR, MDSAP and ISO 9001:2015
Valid passport and ability to travel internationally: Domestic and International Travel will be required of about 35%

Responsibilities

Ensures that Getinge Corporate Internal Audits are completed in compliance with regulatory requirements and documented procedures
Able to coordinate, collaborate and manage audits as lead auditor at various global Getinge locations
Maintain Documentation for Getinge Corporate Internal Audits in Associated databases
Follow up with audited sites for audit nonconformance completion
Ability to track and prepare trend reports on audits and non-conformances
Able to manage conflict resolution that may arise during audit completions
Implement and maintain a system to track and trend internal and external audit results