Quality Systems Specialist — CAPA, Validation & RA Support

Biotech Healthcare; Roscommon; On-site; EUR 36,000 - 38,000; Full time

Job summary

Biotech Europe Meditech Inc. Limited is seeking a Quality Systems Specialist to reinforce the QMS, manage CAPA/NCR processes and ensure ISO13485 – 21 CFR 820 compliance across operations.

The role focuses on complaints handling, environmental monitoring, regulatory affairs support and change control, with cross-functional collaboration to uphold quality standards in a high-volume production environment. Strong data analysis and communication skills are expected as you drive continuous

Qualifications

• Previous work experience in a similar work environment is essential.
• Experience with ISO quality systems (ISO13485 – 21 CFR 820) is required.
• Strong change control and CAPA experience.

Responsibilities

• Manage recording, investigation and resolution of product complaints, problems, or safety issues.
• Run regular Complaint, CAPA, NCR and continuous improvement monitoring meetings.
• Generate KPI data around Complaint, CAPA, NCR and continuous improvement.
• Provide support to Quality Engineering and Operations for Risk Assessments.
• Ensure deviations to protocols are controlled and addressed by the Validation Project Team.
• Coordinate environmental monitoring activities and bioburden/microbial ID monitoring.
• Support Regulatory Affairs with international submissions and RA documentation.
• Assist with change notifications/Validation protocols and Reports.
• Provide ongoing manufacturing support for production transfers.
• Support quality role in new product introductions and transfers to production.
• Internal customer service: maintain data analytics resources for teams.

Skills

High Volume Production

Change control management

ISO13485 / 21 CFR 820

Independent opinion

Communication skills

Attention to detail

Problem solving

Risk Management (FMEA)

Education

School education level

University / technical college education level

Job description

Biotech Europe Meditech Inc. Limited is seeking a Quality Systems Specialist to reinforce the QMS, manage CAPA/NCR processes and ensure ISO13485 – 21 CFR 820 compliance across operations.

The role focuses on complaints handling, environmental monitoring, regulatory affairs support and change control, with cross-functional collaboration to uphold quality standards in a high-volume production environment. Strong data analysis and communication skills are expected as you drive continuous