Quality Assurance Administrator We are seeking a detail-oriented and proactive Quality Assurance Administrator to support our clients Quality Assurance team.
You will be ensuring compliance across the Quality Management System (QMS) in accordance with ISO 13485, IVDR (EU 2017/746), and other applicable regulatory standards.
This role is critical in ensuring the integrity of documentation, audit readiness, and continuous improvement within our medical device operations.
For You: Full-time permanent role.
35k DOE Located in Wicklow with parking.
Join a collaborative and supportive team.
Competitive benefit package.
Primary Responsibilities: Oversee the upkeep and revision of Quality Management System (QMS) documentation, including standard operating procedures, work instructions, and associated records.
Contribute to the development and ongoing support of processes aligned with IVDR requirements.
Organise and manage internal and external audits, including planning, documentation handling, and follow-up on corrective actions.
Provide support for CAPA activities, handling non-conformances, and overseeing change control initiatives.
Track and report on training compliance across all relevant departments.
Assist with risk management efforts in line with ISO 14971 standards.
Ensure proper implementation of document control protocols and secure record archiving.
Work collaboratively with cross-functional teams to maintain compliance with quality and regulatory standards.
Generate and present quality performance indicators and reports for leadership review.
Key Requirements: Strong administrative capabilities.
Ideally, 2+ years of experience in a quality or regulatory capacity within the IVD or medical device sector.
Working knowledge of ISO 13485, IVDR, and ISO 14971 standards.
Excellent organisational and verbal/written communication skills.
Skilled in using document control platforms and Microsoft Office applications.
High attention to detail and ability to balance multiple tasks effectively.
Familiarity with electronic QMS tools (e.g., MasterControl, Veeva, Greenlight Guru).
Understanding of MDR and FDA 21 CFR Part 820 is advantageous.
Prior experience supporting audits (internal, supplier, or notified body).
For more information, please apply through the link provided for the attention of Nikki Moloney or call Osborne Recruitment on .
If you are interested in finding out more about the above role and would like to be considered for this or other suitable roles that we may have available for your skill set please attach your CV via the link provided.
Please submit your updated CV in Word Format.
If you are living in Ireland and hold a VALID WORK PERMIT, we would love to hear from you, if however, you do not hold a valid work permit unfortunately we will not be in a position to assist you with your job search.
Osborne are proud to be an Equal Opportunity Employer.
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