Overview
Join to apply for the QA Inspector 2 role at Dexcom.
Meet the team: Product Testing and Lot Release Department within our Quality Assurance team are looking for a dynamic and skilled Lot Release QA Inspector 2 (Onsite role) to support the start-up of our first European manufacturing site in Athenry. The inspector plays a critical role in ensuring that the products meet all regulatory, quality, and safety standards before being released for commercial use.
Responsibilities
* This role will move to a day shift pattern in 2027, which will be 12-hour shifts (7am – 7pm) every Monday to Wednesday and alternate Thursdays, following a repeating 4-on/3-off – 3-on/4-off schedule.
* Performs in-process and final product review of documents for accurate format, signatures, dating and Good Documentation Practices (GDP) for commercial product in a timely matter.
* Performs in-process product inspection and testing for commercial products as conforming to specified requirements in accordance with product specification and quality assurance standards. Prepares, records, and updates inspection report form.
* Performs transactions related to Lot Release in a defined system.
* Works closely with Quality Engineers, Manufacturing, Process Engineers, Warehouse team and other functions on any issues that arise in relation to the Lot Release process.
* Maintains compliance with operating procedures and ensures training is completed prior to the operation of a task.
* Monitors equipment and instrumentation to ensure there are no issues and equipment is clean, and safe to use.
* Ensures all documentation and labelling is legible, complete, and correct per current Good Manufacturing Practices.
* Assists in setting up the Lot Release Dept. and associated Lot Release Lab.
* Assists in carrying out TMVs and troubleshooting test methods.
* Initiates and assists with the NCMR process during manufacturing of commercial products.
* Adheres to all GMP, safety guidelines and company standards at all times.
* Assumes and performs other duties as assigned.
What Makes You Successful
* Minimum Level 6 in Quality, Engineering or a related discipline.
* 2-4 years’ experience within the medical device industry.
* Strong interpersonal and teamwork skills and written and verbal communication skills.
* Ability to flex to work in different shifts to meet demand.
* Experience with Microsoft Office Products (Word, Excel, Outlook) is desirable.
* Right to work in Ireland.
To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.
Employment details
* Seniority level: Not Applicable
* Employment type: Full-time
* Job function: Quality Assurance
* Industries: Medical Equipment Manufacturing
Athenry, County Galway, Ireland
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