Role Summary
Lot Release QA Inspector 3 – Onsite, fixed evening shift (3:30pm–12:00am, Monday-Friday).
This lab-based role supports the start-up of Dexcom's first European manufacturing site in Athenry.
The inspector ensures all product lots meet regulatory, quality and safety standards before release.
Key Responsibilities
Perform in-process and final product review of documents for accurate format, signatures, dating and Good Documentation Practices (GDP).
Inspect and test in-process products to confirm compliance with specifications and quality standards; record and update inspection reports.
Execute Lot Release transactions in the defined system.
Collaborate with Quality Engineers, Manufacturing, Process Engineers and other functions to resolve Lot Release issues.
Maintain compliance with operating procedures and verify training completion prior to task operation.
Monitor equipment and instrumentation; ensure equipment is clean, safe and fully functional.
Ensure all documentation and labelling are legible, complete and correct per current Good Manufacturing Practices.
Assist in setting up the Lot Release Department and associated lab.
Support transition of test methods through TMVs and troubleshooting.
Initiate and assist with the NCMR process during commercial product manufacturing.
Conduct functional lab tests using microscopy and similar equipment.
Adhere to GMP, safety guidelines and company standards at all times.
Perform additional duties as assigned.
Qualifications
Minimum Level6 in Quality, Engineering or a related discipline.
4–6years of experience in the medical device industry.
Strong interpersonal, teamwork, written and verbal communication skills.
Flexibility to work varying shifts to meet demand.
Proficiency with statistical analysis (e.g., Minitab) and Microsoft Office (Word, Excel, Outlook) is desirable.
Benefits
Front-row seat to life-changing CGM technology and a supportive community.
A full and comprehensive benefits program.
Growth opportunities on a global scale.
Access to career development through in-house learning programs and tuition reimbursement.
Part of an innovative, industry-leading organization committed to employees, customers and communities.
Additional Information
This role is fully onsite in a controlled laboratory environment and requires adherence to established procedures and quality standards.
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