Description
A number of my clients are now planning on adding a number of Medical Device Auditors & Technical File Reviewers over the coming months. These would be field/home based which opens them up to almost everyone as no need to relocate.The Lead Auditor must have, as a minimum, an in depth knowledge of the medical devices directive 93/42/EEC, supporting guidance documents (MEDDEVs etc), ideally also have some knowledge of other national medical regulations, e.g. CMDCAS, TCP, PAL etc. The individual should hold a relevant degree or equivalent and have hands-on experience in the medical devices industry. The individual must be an experienced lead auditor in a medical devices environment (third party audits preferred). We are looking for specific individuals that have spent 1 year+ at a notified body but are looking for a change or a step up.
Activities and requirements
- Plan, confirm, execute and report audits according to the company procedures and routines.
- Manage and mentor audit teams.
- Review responses to action requests within agreed timeframes.
- Conduct special audits as needed.
- Conduct unannounced audits as directed.
- Attend all required calibration events.
- Commit to keep relevant industry knowledge up to date.
- Commit to delivering a minimum number of audit days per annum.
- Be willing to travel nationally and internationally as required.
- Look for opportunities to continually improve the audit process.
- Commit to training and mentoring of new auditors.
- Be willing to act in the capacity of witness auditor.
- Be willing to participate in accreditor witnessed audits.
My client will take salary expectations on a case by case basis, so if you are currently a Notified Body auditor and looking for a change (or know someone who is) then please send me your CV and I will be in touch shortly.