Quality Systems Engineer
Job ID: JOB-11880
Quality Systems Engineer
Our Client, a world leader in advanced medical device design are currently looking for a Quality Systems Engineer to join their team in Galway. Reporting directly to the Quality Systems, and Regulatory Affairs Supervisor, they will primarily be responsible for coordinating, maintaining and improving where necessary all product and process quality systems.
Ensure continued compliance with all Regulatory Standards. This includes:
- ISO 13485
- FDA QSR
- Ensuring continued compliance with DMR
- Co-ordination of the Complaint program and compilation of Complaint metrics.
- Co-ordination of the CAPA program and compilation of CAPA metrics.
- Co-ordination of the Internal Audit Program
- Act as SME (subject matter expert) with respect to internal audit, complaint handling, CAPA handling and the eQMS.
- Takes a leadership role in developing and implementing new techniques and initiatives to enhance the QMS
- Generation of ECO’s and change control documentation as required.
- Management of the supporting elements of the Quality Management system.
- Co-ordinate the internal audit program. Publishing schedules, coordinating with auditors. Generate metrics.
- Participates in external regulatory audits
- Compile weekly/monthly Quality Reports.
- Perform Quality Systems Trending by compiling; weekly/monthly quality reports, raw data for Quality.
- KPIs and trending for Operations Reviews and Management Reviews
- Playing a role in the plant annual objectives.
- Ensure the company behavioral standards are adhered to, setting the example yourself for your direct reports.
- Project meeting attendance as required.
- Ensure that in your absence your department provides adequate day to day service. Ensure that other departments know of your arrangements well in advance.
- Ensuring backup and notification for any absences within the group, and being able to step down when required based on priorities.
- Work efficiently using own initiative, escalating decisions to the QS / RA Supervisor as necessary.
- Engineering or Science Degree
- Minimum 2 years working in a similar role
- Lead Auditor Certificate, desirable.
For further information on this role in please contact Mark Wilson on 0860449473 or email firstname.lastname@example.org
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