Quality Engineer

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

This role would be onsite based in Shannon

JOB PURPOSE: Develop, establish and maintain quality systems and practices which meet the company, customer and regulatory requirements.

PRINCIPAL ACCOUNTABILITIES:

• Ensure compliance with all pertinent regulations (e.g. FDA, ISO)
• Ensure compliance and execute activities to the QMS 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 procedures and forms.
• Support production activities in building quality into products and assuring compliance to the pertinent regulations
• Lead and execute upgrades to the quality system
• Participation, co-ordination and maintenance of the audit system.
• Support customer and regulatory audits
• Ensuring the promotion of the awareness of customer requirements in the company.
• Producing daily management reports with a view to identifying and making recommendations on improvement opportunities.

KNOWLEDGE/EXPERIENCE:

• Bachelors degree in a scientific discipline is an advantage
• Minimum of 3 years in a Quality Assurance role in Medical Device or Pharma is preferred.
• Excellent verbal and written communication skills
• Ability to work in a cross functional team
• Good command of MS Office – Word, Excel, PowerPoint
• Working knowledge and understanding of QSR and ISO quality system requirements
• Lead Auditor certification or previous auditing experience is preferred