Onsite Quality Systems Lead – Regulatory, Audits & CAPA

Harmonics Recruitment; Shannon; On-site; EUR 60,000 - 80,000; Full time

Job summary

Harmonics Recruitment seeks a Quality Assurance professional to be onsite in Shannon, responsible for developing and maintaining quality systems in line with regulatory and customer requirements.

Key duties include ensuring compliance with FDA/ISO, managing CAPA, change control, complaints, document control, and record retention, and supporting production to embed quality throughout products. A science degree and 3+ years in QA are preferred, with auditing experience desirable.

Qualifications

• 3+ years in a QA role within Medical Device or Pharma.
• Excellent verbal and written communication skills.
• Ability to work in a cross-functional team.

Responsibilities

• Ensure compliance with all relevant regulations (FDA, ISO).
• Execute QMS activities such as non-conformance investigations, CAPA, Change control, complaints, document control, and record retention.
• Support DHR reviews to ensure timely release of product.
• Develop, implement and maintain quality procedures and forms.
• Support production activities to build quality into products.
• Lead upgrades to the quality system and maintain audit processes.
• Support customer and regulatory audits.
• Promote awareness of customer requirements across the company.
• Produce daily management reports to identify improvement opportunities.

Skills

Quality Assurance

Regulatory compliance

Cross-functional teamwork

Auditing

Documentation

Education

Bachelor's degree in a scientific discipline

Tools

MS Office

Job description

Harmonics Recruitment seeks a Quality Assurance professional to be onsite in Shannon, responsible for developing and maintaining quality systems in line with regulatory and customer requirements.

Key duties include ensuring compliance with FDA/ISO, managing CAPA, change control, complaints, document control, and record retention, and supporting production to embed quality throughout products. A science degree and 3+ years in QA are preferred, with auditing experience desirable.