Job Description
This role is on a fixed (non rotational) day shift pattern which will be a 12‑hour shift (7 am – 7 pm) every Monday to Wednesday and alternate Thursdays, following a repeating 4‑on/3‑off – 3‑on/4‑off schedule.
This position is primarily cleanroom‑based and involves working in a controlled environment in line with established cleanroom 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 product in a timely manner.
Perform in‑process product inspection and testing for commercial products as conforming to specified requirements in accordance with product specification and quality assurance standards. Prepare, record, and update inspection report form.
Handle 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 a task.
Monitor equipment and instrumentation to ensure there are no issues and equipment is clean, and safe to use.
Ensure all documentation and labelling 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.
Perform any other duties as assigned.
Qualifications
Minimum Level 6 in Quality, Engineering or a related discipline.
2–4 years of experience within the medical device industry.
Strong interpersonal and teamwork skills and written and verbal communication skills.
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.
Benefits
A front row seat to life‑changing CGM technology.
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.
Travel Required
0–5%
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