Date: March or April 2023
Role: Quality Auditor
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
- Positive, can-do attitude
- Gratitude and humility
Our medical device client are seeking an experienced quality auditor who can carry out an MDR mock pre-submission audit onsite in Galway for them in March or April 2023.
- Preparation for audit to understand scope and deliverables
- Review documents, QMS procedures and technical files
- 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 if the QMS has been implemented correctly and maintained correctly
- Recording and documentation of findings
- Attend report out meetings during the audit
- Document records reviewed and personnel interviewed
- A minimum 5 years’ experience carrying out audits in the medical device industry
- Lead auditor qualification is essential
- ISO 13485 audit experience
- Experience with Class II and Class III medical devices
- Bachelor’s degree in Engineering or relevant discipline.
- Please make sure you are currently located within Ireland for this role.
Organised & Detail oriented
- Remote status
- Hybrid Remote
Our Company Culture
People First, Always
Trinzo is a company driven by unshakeable core values: we put people first, from our consultants to our clients, and we value hard work, honesty and integrity above all.
At Trinzo, we strive to create a company culture that encourages each member of the consultancy ecosystem to reach their fullest potential, whether that’s a client with an organizational issue or a consultant with a vision for change.
We help our team to lead the industry in creating solutions, applying well-tested methodologies and persistently seeking innovative ways to help our clients succeed.
Trinzo is a medical device and pharmaceutical consultancy firm that excels at compliance, regulatory and project management issues. We create bespoke solutions for our clients on a project basis and find the root of structural issues.
In many cases, our clients hire us to solve a specific problem or remediate an issue. Sometimes, the issue at hand is only surface-level and our knowledgeable consultants use their industry expertise to design a comprehensive solution. But when the challenges run deeper, Trinzo will get to the heart of the issue, offering insight, advice and industry-leading methodologies that will leave your team stronger, with renewed motivation and increased efficiency.
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