Job Overview
Dexcom Corporation, a global leader in continuous glucose monitoring, is recruiting a Lot Release QA Inspector 3 for the new European manufacturing site in Athenry.
The role is onsite, lab-based, with a fixed morning shift pattern of 7:00am–3:30pm, Monday through Friday.
Responsibilities
Perform in-process and final product review of documents for accurate format, signatures, dating and Good Documentation Practices (GDP) for commercial product in a timely manner.
Inspect and test commercial products in-process, ensuring conformity to product specifications and quality assurance standards.
Prepare, record and update inspection report forms.
Execute Lot Release transactions in the designated system.
Collaborate with Quality Engineers, Manufacturing, Process Engineers and other functions to resolve issues related to Lot Release.
Maintain compliance with operating procedures and verify training completion prior to task execution.
Monitor equipment and instrumentation for cleanliness, safety and operational integrity.
Ensure documentation and labelling are legible, complete and compliant with current Good Manufacturing Practices.
Assist in setting up the Lot Release Department and associated lab.
Carry out Target Method Validation Studies (TMVs) and troubleshoot test methods.
Initiate and assist with the Non-Conformity Management Record (NCMR) process during commercial product manufacturing.
Conduct functional tests in a laboratory environment, using microscopes and similar equipment.
Adhere to all GMP, safety guidelines and company standards.
Perform other duties as assigned.
Qualifications
Minimum Level 6 qualification in Quality, Engineering or a related discipline.
4–6 years of experience within the medical device industry.
Strong interpersonal and teamwork skills with effective written and verbal communication.
Flexibility to work in shifts as needed.
Proficiency with statistical analysis tools (e.g., Minitab) and Microsoft Office Suite (Word, Excel, Outlook) desirable.
Benefits
Access to a comprehensive benefits program.
Opportunities for growth on a global scale.
Career development through in-house learning programs and tuition reimbursement.
Front-row experience with cutting-edge CGM technology.
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