senior QA manufacturing engineer

senior QA manufacturing engineer

We are currently hiring.

Organisation

Indigo Diabetes is a high-tech medical devices scale-up. By exploiting ground-breaking photonics technology, Indigo Diabetes has developed an Active Implantable Medical Device (AIMD): World’s first invisible sensor for people living with diabetes to address their need for accurate glucose monitoring with an improved user experience. Their mission is to light up the life of millions of people living with diabetes and their families through innovative medical technologies.  As the device has not been introduced to the market yet, and the first-in-human clinical research studies are being started, the Senior Manufacturing QA Engineer will be highly involved in the further development of the quality and manufacturing processes.

Function

As a Senior QA Manufacturing Engineer, you will be the “eyes” of the quality department and detect and respond to all issues related to the safety and compliance of the product. You will report to the VP Quality and work in a team with a total of four quality professionals. As this is a small team in a scale-up environment, this role requires a hands-on work ethic. You will perform several quality related tasks and support the manufacturing department with QMS-related activities. This includes tasks related to:

  • Manufacturing: Supporting in creating and maintaining manufacturing instructions and training (records)
  • Verification and validation of manufacturing processes: support IQ/OQ/PQ
  • Non-conforming materials: organising material review board, investigation, root cause determination, scrap, etc
  • Identification of manufacturing materials: execute and monitor
  • Traceability: monitor documentation and traceability in manufacturing process
  • Supplier management: execute and monitor outsourced manufacturing activities
  • Warehousing and Material handling support: create incoming inspection documentation, execute release to manufacturing, monitor manufacturing and labelling
  • Inspection and release of materials and sub-assemblies: inspect test results, perform tests and organise and prepare final release
  • Configuration management: Set up and execute procedure

Requirements

We are looking for a motivated and driven candidate who has a hands-on mentality and at least 5 years prior work experience in a similar role, in a manufacturing/ R&D environment. Additionally, the candidate should meet the following criteria:

  • Bachelor’s/Master’s degree in a technical area
  • At least five years of quality experience in a medical device manufacturing/R&D environment (preferably wafer/photonic)
  • Experience with implementing a QMS based on ISO13485 for a Class III medical device (preferably AIMD)
  • Eligible to work in the EU/Belgium
  • Team player, eager to learn and dedicated to a high degree of accuracy
  • Used to work autonomously within the assigned area of responsibility
  • Used to work in a structured way
  • Able to keep an overview of pending items, follow up on these and be assertive enough to collect input from other parties involved
  • Strong communicator to all levels of the organisation
  • Open to work in a dynamic start-up environment

Offer

This role offers:

  • A high level of responsibility
  • A big role in the further building of the quality department of a promising medical devices scale-up
  • A competitive salary package with market-conform fringe benefits, dependent on experience

Join us today!

Send us your motivation letter and CV (HR@indigomed.com)
We look forward to hearing from you!