QA Inspector 3 - Back End Nights

About the Company

Dexcom Corporation (NASDAQ DXCM) is a global pioneer in continuous glucose monitoring technology. Founded over 25 years ago with a mission to transform diabetes management, Dexcom now aims to empower individuals beyond diabetes through personalized health insights that address significant health challenges. With a passionate global team, Dexcom continues to innovate biosensing technologies to improve human health worldwide.

Job Overview

This role is designated for a fixed night shift working 12-hour shifts from 7pm to 7am every Friday through Sunday and alternate Thursdays, following a rotating schedule of 4-on/3-off and 3-on/4-off days. The position requires working primarily within a controlled cleanroom environment, adhering to strict procedures and quality standards.

Responsibilities

• Conduct in-process and final product document reviews to verify proper format, authorizations, dating, and adherence to Good Documentation Practices (GDP) for commercial products promptly.
• Perform inspection and testing of commercial products during production to ensure conformity with specifications and quality assurance standards, including preparation and updating of inspection reports.
• Manage Lot Release transactions using defined systems accurately.
• Collaborate effectively with Quality Engineers, Manufacturing, Process Engineers, and other departments to address issues during the Lot Release process.
• Comply with operating procedures and complete required training prior to task execution.
• Oversee equipment and instrumentation condition, ensuring cleanliness, safety, and functionality.
• Verify that all documentation and labeling meet legibility, completeness, and Good Manufacturing Practices (GMP) requirements.
• Assist in establishing the Lot Release Department and its associated laboratory.
• Support method validation activities and troubleshooting of test methods.
• Initiate and aid Non-Conforming Material Reports (NCMR) during product manufacturing.
• Maintain adherence to all GMP, safety guidelines, and company policies consistently.
• Perform additional duties as assigned by management.

Qualifications

• Minimum Level 6 qualification in Quality, Engineering, or a related field.
• Between 4 and 6 years of relevant experience in the medical device industry.
• Strong teamwork, interpersonal, and communication skills (both written and verbal).
• Flexibility to work varying shifts as required to meet operational demands.
• Familiarity with statistical analysis tools such as Minitab and proficiency in Microsoft Office applications (Word, Excel, Outlook) is desirable.

Benefits

• Opportunity to work with cutting-edge CGM technology impacting lives globally.
• Comprehensive benefits package.
• Global career advancement prospects.
• Access to professional development including internal learning programs and possible tuition reimbursement.
• Work within an innovative, leading organization committed to its people, customers, and communities.

Additional Information

This position involves work in a highly regulated, cleanroom manufacturing setting with rotating twelve-hour night shifts. Candidates should be prepared to operate within strict quality and safety standards. Only direct applicants should apply; unsolicited resumes from recruiting agencies will not be accepted.