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Senior Quality Control Specialist

3 weeks ago

Bray, Wicklow, Ireland beBeeRegulatory Full time

Job Title: Quality Assurance Specialist

We are seeking a detail-oriented and proactive professional to support our Quality Assurance team. The successful candidate will be responsible for 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. We offer a full-time permanent position with a competitive benefit package.

  • 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.
  • Generate and present quality performance indicators and reports for leadership review.

Required Skills and Qualifications:

  • Strong administrative capabilities.
  • 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).

Benefits:

  • Full-time permanent position.
  • Competitive benefit package.
  • Located in Wicklow with parking.
  • Collaborative and supportive team environment.

Others:

  • Submit your updated CV in Word Format.
  • Living in Ireland and hold a VALID WORK PERMIT.