Medical Device Assessors

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A number of my clients are now planning on adding a multiple 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).

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.

Essential Requirements

* 4-5 Years experience working within a Medical Device company

* Strong experience of Audit of a Medical Manufacturing environment/Quality Management Systems (13485)

* Available to travel when needed to client sites to perform audits.

* Good technical understanding of the development & design of Medical Devices would be beneficial but not essential.

* Ability to be customer facing with good communication skills.

My client will take salary expectations on a case by case basis but are paying above industry rate, so if you believe you have the required experience (or know someone who has) then please send me your CV and I will be in touch shortly.