Government, Regulatory and Code, Quality, Quality Engineering
Corporate Management of the Internal Auditing within Getinge sites under Consent Decree. Manage the Corporate Internal Audit processes to improve compliance throughout the sites under Consent Decree, providing early warning of noncompliance with the Consent Decree, Quality System and other regulatory requirements. This role requires some international travel.
Follow Corporate Auditing Procedures for Internal Auditing of sites under Consent Decree.
Perform or arrange Corporate Internal Audits for all Getinge sites under Consent Decree.
Assist in development and implementation of a Corporate Audit Schedule for all Getinge sites under Consent Decree.
Identify auditor qualifications and train auditors to perform Corporate Internal Audits.
Monitor Corporate Internal Audit Corrective Actions Plans to completion.
Monitor the Corrective Actions Plans to address FDA and third party expert findings for all Getinge sites under Consent Decree.
Establish Check-lists for auditing to applicable regulations, directives, standards, and the Consent Decree.
Manage a team that is responsible for the Corporate Internal Audit program for sites under Consent Decree.
Perform as the Lead Auditor for corporate internal audits for all Getinge sites under Consent Decree.
Manage personnel, as required, both internal and external third party auditors, to conduct internal audits for all Getinge sites under Consent Decree.
As appropriate, establish an audit team and manage the team to perform audits.
Ensure that internal audits are copleted in a manner that provides early detection of noncompliance with regulations and prepares sites for continued inspections by the third party experts and/or FDA.
Submit audit reports in a timely manner.
Ensure that Corrective Action Plans (CAPs) are established for identified con-conformance's within established time lines.
Verify CAPA's are implemented at next audit.
Bachelor’s degree in life sciences or equivalent work experience
ASQ Certification - Internal Auditor ISO 13485 required.
Minimum 5 years related experience in Medical Device Quality or Regulatory Affairs
Previous background and experience in Quality or Regulatory Affairs
Strong knowledge and experience in development of Audit Schedules and Auditing
Successful interactions with all levels of personnel
Excellent knowledge of Regulations worldwide
Getinge Group is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.
Getinge Group is a leading global provider of products and systems that contribute to quality enhancement and cost efficiency within healthcare and life sciences. The aim is to be the most desired medtech company in the world.Getinge's offering is mainly targeted at care providers, care givers and care receivers. The offering to hospitals is organized in three areas: Enable, Treat and Care. This a...llows Getinge to identify customer issues at an early stage, promote clinical and economic benefits and follow and support the customer decision process. Getinge's unique offering mirrors the hospital's organization and value chain, and the solutions are used before, during and after the patients' hospital stay.