Overview
Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. We are 25 years in, broadening our vision beyond diabetes to empower people to take control of health with personalized, actionable insights aimed at solving important health challenges. Our focus is on improving human health at a global scale.
Meet the Team: Product Testing and Lot Release Department within our Quality Assurance team is looking for a dynamic and skilled Lot Release QA Inspector 3 (Onsite role) to support the start-up of our first European manufacturing site in Athenry. The inspector plays a critical role in ensuring that products meet regulatory, quality, and safety standards before release for commercial use. Responsibilities include ensuring Lot Release activities are performed to company standards and methods as determined by Quality Assurance or other Engineering departments.
Responsibilities
* 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 manner.
* Performs in-process product inspection and testing for commercial products to conform to specified requirements in accordance with product specification and quality assurance standards. Prepares, records, and updates inspection report forms.
* Perform transactions related to Lot Release in a defined system.
* Work closely 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 performing a task.
* Monitor equipment and instrumentation to ensure there are no issues and that equipment is clean and safe to use.
* Ensure all documentation and labeling is legible, complete, and correct per current Good Manufacturing Practices.
* Assist in setting up the Lot Release Department and associated Lot Release Lab.
* Assist in carrying out TMVs 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.
* Assume and perform other duties as assigned.
Qualifications
* Minimum Level 6 in Quality, Engineering or a related discipline.
* 4-6 years of experience within the medical device industry.
* Strong interpersonal and teamwork skills and written and verbal communication abilities.
* 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.
What You’ll Get
* A front row seat to life changing CGM technology and the Dexcom warriors community.
* A 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.
* An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.
Travel Required
* 0-5%
To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Dexcom does not accept unsolicited resumes or applications from agencies. Dexcom is not responsible for any fees related to unsolicited resumes/applications.
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