QA Inspector 3 Lot Release (Evening Shift) Athenry, Ireland
Posted 24 minutes 27 seconds ago by Job Search Place Limited
Permanent
Full Time
Other
Not Specified, Ireland
Job Description
About the Role 
Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). The position is a fixed, non rotational evening shift (3:30pm 12:00am, Monday to Friday) and is primarily lab based, requiring work in a controlled environment in line with established procedures and quality standards.
Responsibilities- Perform in process and final product review of documents for accurate format, signatures, dating and Good Documentation Practices (GDP) for commercial products in a timely manner.
- Inspect and test in process products to ensure compliance with specified requirements and quality assurance standards.
- Prepare, record, and update inspection report forms.
- Execute lot release transactions in the defined system.
- Collaborate with Quality Engineers, Manufacturing, Process Engineers and other functions to resolve issues related to the lot release process.
- Maintain compliance with operating procedures and verify training completion before task operation.
- Monitor equipment and instrumentation for functionality, cleanliness, and safety.
- Ensure all documentation and labeling are legible, complete, and correct per current Good Manufacturing Practices.
- Assist in establishing the Lot Release Department and associated lab.
- Conduct TMVs (trials, mock vets) and troubleshoot test methods.
- Initiate and assist with the non conforming material report (NCMR) process during manufacturing of commercial products.
- Perform functional tests in a lab environment, familiar with microscopes and similar equipment.
- Adhere to GMP, safety guidelines, and company standards at all times.
- Carry out additional duties as assigned.
- Minimum Level6 in Quality, Engineering or a related discipline.
- 4-6years of experience within the medical device industry.
- Strong interpersonal and teamwork skills, with written and verbal communication proficiency.
- Ability to flex to work in different shifts to meet demand.
- Proficiency with statistical analysis (e.g., Minitab) and Microsoft Office products (Word, Excel, Outlook) is desirable.
- Front row seat to life changing CGM technology and community engagement.
- Full and comprehensive benefits program.
- Growth opportunities on a global scale.
- Access to career development through in house learning programs and/or qualified tuition reimbursement.
- Exciting and innovative, industry leading organization committed to employees, customers, and the communities we serve.