Vacancy – Junior QA Employee

Vacancy: Junior QA Employee

LipoCoat BV – Enschede
Drive development of our technology to the next level. Be part of a fast-growing, high-potential, high-tech company. Make impact and join our mission to improve the performance, comfort and safety of medical devices.

Who we are
LipoCoat is a life sciences spin-off from the University of Twente, founded in 2016. Our brand new HQ and lab facility are situated on the innovation campus of the University of Twente in Enschede, The Netherlands. LipoCoat has developed the first bio-inspired, non-toxic antibacterial coatings for medical devices, which reduce the infection risk by 95% and can be used for e.g. catheters, contact lenses and prostheses. In the past 3 years, LipoCoat has won 18 honors and awards, including European Biotech Startup of 2019, and entered the Global Top 10 Catheter Coatings Market Players.

LipoCoat currently has 14 employees with multidisciplinary expertise in chemistry, technology development, business development, entrepreneurship and commercialization. The LipoCoat team is gender diverse, multicultural and intergenerational.

Role description
You will be part of an quality team. In this role you will assist to maintain and improve our Quality Management System to ensure regulatory compliancy and product quality.

Responsibilities

  • Ensure correct document and records control
  • Review of operational SOP’s and Work Instructions as needed; review and approve deviation (CAPA) records
  • Assist in internal audits and the follow up of audit findings
  • Review validation protocols for manufacturing
  • Ensure correct approval of products
  • Participate in QA production related projects as needed
  • Responsible for monitoring key processes
  • Assist in writing and maintenance of medical device files

Requirements

  • Startup mentality: driven, proactive, flexible, problem solver, team player
  • Fluently speaking Dutch and English
  • BSc or MSc background in Biomedical, Life Sciences or related field
  • (preferably) a first experience within QA or manufacturing processes
  • (preferable) knowledge of Quality Management Systems

 What we offer

  • Working for a high-tech scale-up with an extremely innovative, high-impact product
  • A great work environment with a hardworking, fun and informal team
  • Working in a high-tech environment (University of Twente Innovation Campus) with access to a wealth of knowledge
  • The ability to do a wide variety of tasks
  • Support to help you grow as a professional
  • Market rate salary
  • Initially a one-year contract, which can be extended and grow into a permanent position

Nice to have

  • Experience with ISO 13485 or ISO 9001
  • Experience with contract research

How to apply
For more information or to apply directly, please send an email to Iris Wiggers at hr@lipocoat.com that includes your resumé and a cover letter.

LipoCoat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for our team members. We hire on the basis of qualifications, merit, and business need. We look forward to receiving your application!