QA Inspector 3 Back End Nights

Job Overview

Lot Release QA Inspector 3 (Onsite role) - fixed non rotational night shift pattern, 12 hour shift (7pm-7am) Fridays, Saturdays, Sundays, and alternate Thursdays following a repeating 4 on/3 off - 3 on/4 off schedule. Cleanroom based, following established cleanroom procedures and quality standards at the new European manufacturing site in Athenry.

Responsibilities

• Perform in process and final product review of documents for accurate format, signatures, dating and Good Documentation Practices.
• Inspect and test in process products in accordance with product specifications and quality assurance standards.
• Prepare, record, and update inspection reports.
• Execute Lot Release transactions in the defined system.
• Collaborate with Quality Engineers, Manufacturing, Process Engineers and other functions on issues related to the Lot Release process.
• Maintain compliance with operating procedures and ensure training is completed prior to task operation.
• Monitor equipment and instrumentation to ensure cleanliness and safety.
• Ensure all documentation and labeling is legible, complete, and conforming to Good Manufacturing Practices.
• Assist in setting up the Lot Release department and its laboratory.
• Assist in performing transfer of manufacturing validation (TMV) activities and troubleshooting test methods.
• Initiate and assist with the NCMR process during manufacturing of commercial products.
• Adhere to all GMP, safety guidelines and company standards at all times.
• Perform other duties as assigned.

Qualifications

• Minimum Level6 in Quality, Engineering or a related discipline.
• 4-6years of experience within the medical device industry.
• Strong interpersonal, teamwork, written and verbal communication skills.
• Ability to flex to work in different 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.
• Participation in the Dexcom community and access to in house learning programs.
• Full and comprehensive benefits program.
• Growth opportunities on a global scale.
• Career development through learning programs and qualified tuition reimbursement.
• Innovative, industry leading organization committed to employees, customers and communities.