Product Quality Assurance & CAPA Specialist

Abbott; Longford; On-site; EUR 42,000 - 62,000; Full time

Job summary

Abbott in Ireland is seeking a PQA Specialist to ensure complaints, risk evaluations, and related quality activities comply with ISO 13485 and regulatory requirements. You will manage investigations, documentation, and communications across the organization, supporting CAPA and post-market surveillance.

Ideal candidates have a Bachelor’s in a natural science or related field, 1–2 years in medical devices or regulated manufacturing, and strong analytical and communication skills.

Qualifications

• The role requires a Bachelor’s degree in Natural Sciences, Biotechnology, Quality Engineering, Life Sciences, or related field.
• 1–2 years’ experience in Medical Device/regulated manufacturing quality environments is preferred.
• Experience with complaint handling, post-market surveillance, CAPA, or quality systems activities.

Responsibilities

• Handle product complaints and customer communications and close investigations.
• Track status of complaints and external communications and document results.
• Perform trend analysis to identify recurring issues and risks.
• Support CAPA investigations and quality system activities as needed.
• Ensure quality records are maintained and regulatory requirements are met.

Skills

Quality problem-solving

Analytical thinking

Written communication

Stakeholder management

Education

Bachelor's degree in Natural Sciences or related

Postgraduate qualification preferred

Job description

Abbott in Ireland is seeking a PQA Specialist to ensure complaints, risk evaluations, and related quality activities comply with ISO 13485 and regulatory requirements. You will manage investigations, documentation, and communications across the organization, supporting CAPA and post-market surveillance.

Ideal candidates have a Bachelor’s in a natural science or related field, 1–2 years in medical devices or regulated manufacturing, and strong analytical and communication skills.