Quality Assurance Specialist
Job Description:
We are seeking a detail-oriented and proactive Quality Assurance Administrator to support our clients quality assurance team.
The successful candidate will ensure compliance across the quality management system (QMS) in accordance with ISO 13485, IVDR, 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.
Key Responsibilities:
* Oversee the upkeep and revision of 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.
Requirements:
* Strong administrative capabilities.
* Ideal candidates will have 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).
Benefits:
* Full-time permanent role.
* 35k DOE Located in Wicklow with parking.
* Competitive benefit package.