Associate Quality Systems Engineer
Our client, a medical device company in Galway is currently looking to recruit a Associate Quality Systems Engineer for their SiteJob Summary:
Contributes to key elements of the Quality System to ensure compliance to relevant standards for the business including EN ISO13485:2016, FDA QSR. Participates in ensuring that the quality system is maintained and implemented in a compliant manner and areas of improvement are identified and implemented as required. This will involve coordinating and working with all functions in a collaborative manner where quality system compliance is dependent.
- Participate in the Internal Audit program to ensure that all audits assigned are completed in a thorough and timely manner.
- Complete Customer complaints reporting, investigating and trending in a thorough and timely manner.
- Compile data for monthly quality scorecards and management review in an accurate and timely manner.
- Assists with the implementation and monitoring of a complaints software database.
- Participate in the preparation and coordination activities for external audits and liaise as required with SME’s to ensure audits are conducted in an efficient manner.
- Creating and maintaining company documentation, such as quality manuals, and quality procedures.
- Supports Quality systems training on site.
- Participate in weekly quality meetings and complete tasks assigned.
- Contribute to the Quality System team to help make necessary improvements and changes.
The Ideal Candidate:
- A degree in Engineering, Technology, or Science
- At least 2 years’ experience working in a regulated medical device or pharmaceutical company.
- Excellent planning and coordination skills.
- Excellent verbal and written communication skills.
- Excellent attention to detail skills.
For further information on this Associate Quality Engineer role in Galway please contact Orla on 086 0449473/ Talent@hero.ieCheck out all our open jobs on our HERO Recruitment website – https://www.hero.ie/
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