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Senior Supplier Quality Engineer

Employer
Planet Pharma Staffing Limited
Location
Galway (County), Connacht (IE)
Salary
Competitive
Start date
22 Dec 2020
Closing date
21 Jan 2021

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Discipline
Clinical Research, Clinical Supplies
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

The Company:

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!

The Role:

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.  

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.

Company

Planet Pharma was founded by a dedicated team of professionals with extensive experience supporting the pharmaceutical, biotechnology, and device industries.

Our goal is to create an organization that strengthens the employer-employee dynamic by connecting clients with talent. This results in making staffing more personal and creating enduring, valuable relationships. We value communication with our clients and make it our priority to have the hiring process be as fast and successful as possible.

We leverage cutting-edge technology and flexible service delivery models that provide efficient, personalized solutions for your business.

Our global headquarters is in Northbrook, IL and branch offices are based across the United States and Europe.

Company info
Website
Telephone
+44 203 868 1000
Location
10 Greycoat Place
London
England
SW1P 1SB
United Kingdom

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