QA Inspector 3 (Back End Days)

Shift Pattern

This role is on a fixed (non rotational) day shift pattern, working 12 hour shifts from 7am to 7pm every Friday, Saturday, Sunday and alternate Thursdays, following a repeating 4 on / 3 off - 3 on / 4 off schedule.

Responsibilities

• Perform in process and final product review of documents, ensuring accurate format, signatures, dating and compliance with Good Documentation Practices (GDP) for commercial products.
• Inspect and test in process product samples in accordance with product specifications and quality assurance standards.
• Prepare, record and update inspection report forms.
• Execute Lot Release transactions within the designated system.
• Collaborate with Quality Engineers, Manufacturing, Process Engineers and other functions to resolve Lot Release related issues.
• Maintain compliance with operating procedures and ensure training is completed prior to task execution.
• Monitor equipment and instrumentation to confirm no issues and that equipment is clean and safe to use.
• Verify that all documentation and labeling are legible, complete, and correct in accordance with Good Manufacturing Practices (GMP).
• Assist in setting up the Lot Release department and associated laboratory.
• Support the execution of Targeted Methods Verification (TMVs) and troubleshoot test methods.
• Initiate and assist with Non Conformance Material Review (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 and teamwork skills; excellent written and verbal communication.
• Flexibility to work within the required shift schedule.
• Proficiency with statistical analysis (e.g., Minitab) and Microsoft Office (Word, Excel, Outlook) is desirable.

Benefits

• 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.
• A front row seat to life changing CGM technology.