About the Company
Our client is a well-established healthcare packaging manufacturer based in Co. Offaly, partnering with some of the leading global organisations in the medical device and pharmaceutical sectors.
About the Role
This is an onsite Senior Quality Assurance Engineer role in Co. Offaly, supporting manufacturing operations and ensuring compliance with regulatory and quality standards.
The role offers a competitive salary, benefits, and strong career progression opportunities while working with industry-leading global clients.
Ideal for candidates with experience in a regulated manufacturing environment, including medical devices or ISO regulated industries.
Responsibilities
- Maintain and improve the Quality Management System (QMS) in line with ISO and regulatory standards
- Support and lead internal, customer, and regulatory audits from preparation through to close-out
- Drive non-conformance investigations, root cause analysis, and CAPA management
- Provide day-to-day quality support to manufacturing operations and review key documentation
- Support validation activities and change control processes
- Analyse quality data and lead continuous improvement initiatives across the site
- Act as a key quality contact for stakeholders, including supplier quality and customer complaint investigations
Requirements
- Degree qualified in Science, Engineering, or a related discipline
- Minimum 3+ years’ experience in a quality engineering role within a regulated manufacturing environment (essential)
- Strong knowledge of Quality Management Systems (QMS) and regulatory standards (e.g. ISO 13485, ISO 9001, FDA)
- Experience with risk management tools (FMEA) and statistical analysis
- Proven experience in CAPA, audits, and non-conformance investigations
- Previous experience team management experience
What’s Next
If you’re interested in this Senior Quality Assurance Engineer job in Co. Offaly, apply now or contact Tina at Sigmar for a confidential discussion.
We’ll review your application and support you through each stage of the process.
