Medical Device Inspector

2 days ago

Athenry, Galway, Ireland beBeeInspector Full time €52,000 - €74,000

The Company is a pioneer and global leader in continuous glucose monitoring (CGM). It began with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started.

We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more.

We are broadening our vision beyond diabetes to empower people to take control of their health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.

Meet the team
Product Testing and Lot Release Department within our Quality Assurance team are looking for a dynamic and skilledLot ReleaseQA Inspector 2(Onsite role) to support the start-up of our first European manufacturing site in Athenry.

This position plays a critical role in ensuring that products meet all regulatory, quality, and safety standards before being released for commercial use. The inspector ensures 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.

Key Responsibilities:

  • 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, Warehouse team 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
  • To be 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.
    • Experience Microsoft Office Products (Word, Excel, Outlook ) is desirable

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