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Medical device compliance professional

Cork
beBeeCompliance
Posted: 14 August
Offer description

Quality Assurance Specialist

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This role supports quality activities across manufacturing and product development, focused on maintaining high standards and continuous improvement. You will report to the Site Lead and collaborate closely with a global Quality team.

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* Support compliance to regulatory requirements, including ISO 13485 and FDA QSR;
* Assist with risk management and investigations, internal non-conformances, and CAPA activities;
* Conduct Device History Record (DHR) reviews and support equipment calibration as needed;
* Assist with internal audits and document control in line with global quality management system requirements;
* Maintain compliance with health and safety standards.
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Requirements:

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* Bachelor's degree in Engineering, Life Sciences, or a related field;
* 3-5 years' experience in a medical device manufacturing environment;
* Working knowledge of ISO; familiarity with ISO 17025 and FDA QSR desirable;
* Strong analytical, communication, and organisational skills;
* Proficiency in Microsoft Office (Word, Excel, Outlook).
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Why Work With Us?

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This is an excellent opportunity to work for an innovative and supportive organisation that values continuous improvement and professional development.

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The team is small and collaborative, with regular contact with global colleagues and access to training and development.

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Benefits:

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* Negotiable compensation package;
* Healthcare benefits;
* Pension plan.

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