Quality Engineer
Location: Shannon, Co. Clare
Job Type: Permanent / Full-time
Salary: Competitive salary with healthy benefits
About the Role
We’re hiring a Quality Engineer to join a growing life sciences company based in Shannon. This is a hands-on quality role in a GMP-regulated environment supporting cold chain logistics, warehousing, and supply chain operations.
As the role is based within the Shannon Aerospace campus, the successful candidate will be required to complete a security background check as part of the onboarding process. This clearance typically takes 6–8 weeks to complete.
You’ll focus on driving quality compliance, introducing SOPs, and managing change controls to support operations in the life sciences space.
Key Responsibilities
- Write and implement SOPs across warehouse, logistics, and supply chain functions.
- Manage and coordinate change control processes aligned with GMP guidelines.
- Lead or support investigations into deviations, non-conformances, and customer complaints.
- Drive CAPA implementation and support root cause analysis.
- Monitor quality KPIs and trends, and support continuous improvement.
- Ensure compliance with GMP, GDP, and regulatory standards (HPRA, FDA).
- Liaise with internal teams to ensure quality is built into all aspects of operations.
- Support audits and inspections, maintaining a strong state of readiness.
Key Requirements
- Degree in Science, Engineering, or a related field.
- 2–5 years’ experience in a GMP-regulated environment (pharma, biopharma, logistics, or medtech).
- Experience creating and managing SOPs and change control processes.
- Understanding of cold chain, warehousing, and supply chain quality requirements.
- Strong knowledge of QMS processes, CAPA, and deviation management.
- Strong attention to detail with a proactive and collaborative approach.
Desirable
- Exposure to quality in a 3PL, warehouse, or temperature-controlled logistics setting.
- Familiarity with ISO 13485, GDP, and QMS platforms like TrackWise or Veeva.
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