Work for a growing medical device company that values customer focus, teamwork, respect, integrity, communication and innovation. They are already a large presence in the medtech sector globally and their Galway site will be further delving into cardiovascular devices in the near future.
- Ensure compliance to ISO13485, FDA QSR and DMR.
- Co-ordinate the complaint program, managing the metrics for both complaints and CAPAs.
- Act as SME for internal audits, complaint handling and CAPA handling in relation to the eQMS.
- Provide leadership to develop and implement new techniques and initiatives to improve QMS.
- Assist in managing and improving the QMS for the site.
- Compile weekly and monthly quality reports.
- Generation of ECO’s and change control documentation as required.
- Perform Quality Systems Trending and review raw data for Quality KPIs and trending for Operations Reviews.
- Engineering or science degree with a good working knowledge of QMS management and improvement in a medical device or similarly highly regulated environment.
- Knowledge of eQMS modules / processes such as Complaints, CAPA etc.
To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E: firstname.lastname@example.org
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