Senior Supplier Quality Engineer
- Experience Level
- Experienced (non-manager)
They have been around 12 years and were funded by investors initially and then a global Pharma company acquired them and now they are firing on all cylinders, hiring in Germany and US as well as UK and Ireland. Company currently around 70 people, 45 of those in Galway and next year they are looking to add another 50% by hiring 20 more people in Galway alone. They have one product on the market here that is CE marked, approved in the US Oct, 2018 and moving towards approval in APAC!
Their technology aims to replicate nature, as such, their stent is a helical shape, designed to mimic the natural geometry of the vascular system. This is genuinely ground-breaking in the stent world which has previously been governed by tired technology in one if the biggest killers in the world - heart disease. Rather than being situated in the heart it is designed to be in the leg to help prevent clots and keep things moving - the shape is designed to encourage blood to swirl through.
They are fully funded, having a product on the market, and having development plans in place for the next 5-10 years all in the space of a year.
They are also looking into having a drug on board as well to create a combination product... watch this space!
You will need to have a strong team-work ethic as you will be working closely with internal and external stakeholders to ensure the effective supply of high-quality finished product for development projects, clinical and commercial activities. Your role will be to support the Quality Manager in ensuring that the product is manufactured, released and distributed in accordance with the relevant quality and regulatory requirements.
- 5-7 years in medical device, at least 4 of which in a manufacturing role.
- Experience of managing subcontractors + suppliers.
- Experience in process validation and risk management.
- Experience in Class III medical device – ISO 13485; 21 CFR 820 and MDD/MDR as well as quality management systems.
- CAPA, auditing and risk management – ISO 14971 including FMECA.