QA Inspector 2

36 Dexcom International Limited; Athenry; On-site; EUR 32,000 - 42,000; Full time

Benefits offered by this job

Life-changing CGM technology

Dexcom warriors community

Comprehensive benefits program

Global growth opportunities

Career development / tuition support

Job summary

36 Dexcom International Limited in Athenry is seeking a Lot Release QA Inspector 2 (onsite) to support the start-up of our first European manufacturing site. You will review in-process and final documents for GDP, inspect products, and perform Lot Release transactions to ensure regulatory and quality standards are met.

You will collaborate with Quality Engineers, Manufacturing and Process Engineers, monitor equipment, ensure GMP-labelling, and assist in establishing the Lot Release Lab while

Qualifications

• Minimum Level 6 in Quality, Engineering or related discipline.
• 2-4 years’ experience in the medical device industry.
• Strong interpersonal and teamwork skills and written and verbal communication.
• Ability to flex to work in different shifts to meet demand.
• Minitab proficiency and MS Office familiarity (desirable).

Responsibilities

• Review in-process and final documents for GDP and quality standards.
• Perform in-process product inspection and testing per specifications.
• Prepare, record, and update inspection reports.
• Execute Lot Release transactions in the defined system.
• Collaborate with Quality Engineers, Manufacturing, and Process Engineers on Lot Release issues.
• Maintain compliance with operating procedures and ensure training is completed.
• Monitor equipment cleanliness and safety.
• Ensure documentation and labelling meet GMP.
• Assist in setting up the Lot Release Dept and Lab.
• Assist with TMVs and troubleshooting methods.
• Initiate and assist with the NCMR process.
• Adhere to GMP and safety guidelines.
• Perform other duties as assigned.

Job description

Job Description

*This role is on a fixed (non rotational) day shift pattern which will be a 12-hour shift (7am – 7pm) 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.

Meet the team:

Product Testing and Lot Release Department within our Quality Assurance team are looking for a dynamic and skilled Lot Release QA Inspector 2 (Onsite role) to support the start-up of our first European manufacturing site in Athenry. As a member of the Lot Release team, the inspector plays a critical role in ensuring that the products meet all regulatory, quality, and safety standards before being released for commercial use. The inspector is responsible for ensuring the activities related to product Lot Release are performed in a manner which meets company standards and methods as determined by the Quality Assurance or other Engineering departments.

Where you come in:

• 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 matter.


• Perform in-process product inspection and testing for commercial products as conforming to specified requirements in accordance with product specification and quality assurance standards.


• Prepares, records, and updates inspection report form.


• You will perform transactions related to Lot Release in a defined system.


• You will 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.


• You will 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 Dept. and associated Lot Release Lab.


• You will assist in carrying out TMVs and troubleshooting test methods.


• Initiate and assist with the NCMR process during manufacturing of commercial products.


• Adheres to all GMP, safety guidelines and company standards at all times.


• You will assume and perform other duties as assigned.

What makes you successful:

• You will have a minimum Level 6 in Quality, Engineering or a related discipline.


• You will have 2-4 years’ experience within the medical device industry.


• You can demonstrate strong interpersonal and teamwork skills and written and verbal communication skills.


• You must be able 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.


• Learn about our brave #dexcomwarriors 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%

The annualised base salary for this position is from €32,130.00 to €41,580.00 gross. Final offer will depend on your qualifications, competencies, and professional experience.

Since 1999, Dexcom has simplified and revolutionized diabetes management, positively impacting millions worldwide. At Dexcom, we're more than just a medical device company; we're a collective of visionary thinkers, trailblazers, and problem solvers. Our mission transcends the ordinary. We aim to revolutionize healthcare, one groundbreaking technology at a time.