Compliance Quality Engineer

Compliance Quality Engineer wiwith 3+ years experience within a Medical Devices sector. Successful candidate will be talented Engineer with strong auditing experience.

Role:
Lead & participate actively in the internal audits conducted per audit schedule.
* Maintenance of audit schedule.
* Preparation of audit reports listing audit findings to be reviewed and approved by management.
* Support relevant areas in preparation of response plans to audit findings-both internal and
external.
* Inputting audit responses on the electronic Medtronic Audit System.
* Drive preparations for hosting of external audits at Medtronic Galway.
* Drive on time closure of audit actions through use of electronic reporting systems and consistent
communication with relevant personnel and their one-over-managers/supervisors.
* Participate in audit council conferences and communication of relevant issues to personnel
at Medtronic Galway.
* Generation and approval of change requests
* Provide support to Quality Systems re system/process improvements.
* Prepare weekly reports for inclusion in weekly senior site reports.
* Verification of checklist for adherence to Part 11 for software applications.
* Data integrity audits for submissions.

Skills and Education:
A third level degree in a relevant area such as Science, Engineering or equivalent is essential.
(Further postgraduate study in Quality related disciplines would be of benefit).
* Understanding, and preferably, training in the relevant Regulations e.g 21 CFRs Part 820,
210/211, ISO 13485:2003, MDD & AIMD essential.
* Previous auditing experience, preferably as a Lead Auditor, essential.
* Certification to recognized Lead Assessor qualification essential.
* Excellent Verbal and written communication skills are essential for this role, together with an
ability to be self directed and to effectively interface with various levels and functions across
the organization.

Please call Rachel Lane for more details on 00353 22 46969 or email rlane@cbsbutler.com