QA Inspector 2 (Back End Day Shift)

Lot Release QA Inspector 2 (Onsite role) Shift Details

This role is on a fixed (non rotational) day shift pattern which will be a 12 hour shift (7:00 AM - 7:00 PM) every Friday to Sunday and alternate Thursdays, following a repeating 4 on/3 off - 3 on/4 off schedule.

Shift Premium: 15% premium only for Saturday/Sunday, no shift premium for Thursday/Friday.

Responsibilities

• Perform 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.
• Perform in process product inspection and testing for commercial products in accordance with product specifications and quality assurance standards.
• Prepare, record and update 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 any issues that arise in relation to the Lot Release process.
• Maintain compliance with operating procedures and ensure training is completed prior to the operation of any task.
• Monitor equipment and instrumentation to ensure there are no issues and 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 laboratory.
• Assist in carrying out transferability verification (TMV) studies and troubleshooting test methods.
• Initiate and assist with the Nonconformance Management Report (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.
• Work in a cleanroom environment, following established cleanroom procedures and quality standards.

Qualifications

• Minimum Level 6 in Quality, Engineering or a related discipline.
• 2-4 years' experience within the medical device industry.
• Strong interpersonal, teamwork and communication skills.
• Ability to work flexible shifts to meet demand.
• Proficiency with statistical analysis (e.g., Minitab) and Microsoft Office Products (Word, Excel, Outlook) is desirable.

Benefits

• A front row seat to life changing continuous glucose monitoring technology.
• Opportunity to learn about our brave 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 employees, customers and the communities we serve.