Auditor

Auditor Date: 7th-11th of October 2024 Location: Minnesota Role: Auditor About Trinzo: Trinzo is a Medical Device and Pharmaceutical consultancy firm based in Galway, Ireland that specialises in providing our clients, who are Global Leaders in the Medical Device and Pharmaceutical Industry with Quality, Compliance, Regulatory and Project Management expertise.
Trinzo’s Core Values: High performance Value focused Teamwork/collaboration Positive, can-do attitude Gratitude and humility Trusting Our medical device client are seeking a highly experienced auditor who can carry out an audit of their clinical programs.
The audit will be onsite in Minnesota with prep and post work being able to be done remotely.
Responsibilities: Preparation for audit to understand scope and deliverables Review documents Assist with audit agenda preparation Onsite audit focusing on in depth system analysis to identify compliance with local, national and international regulations as applicable Investigate processes around the clinical program to ensure they are being implemented and maintained correctly Recording and documentation of findings Attend report out meetings during the audit Document records reviewed and personnel interviewed Role Requirements: A minimum 5 years’ experience carrying out audits in the medical device industry Extensive experience working in clinical programs previously Lead auditor qualification highly desirable Prior experience working with FDA and European regulations Medical Device and or Pharmaceutical industry experience is essential.
Bachelor’s degree in Engineering or relevant discipline.
Openness to travel to Minnesota during the above mentioned dates Key Attributes: Team Leader Decision Maker Team Motivator Organised & Detail oriented Excellent Communicator Self Sustained