Quality Engineer

  • Ostoform Limited
  • Remote
  • 04/11/2021
Full time QA-Quality Control

Job Description

Title: Quality Engineer

Position: Full-Time

Overview:

Ostoform is an exciting and multiple award-winning Class I Medical Device start-up company with a novel technology that is improving the lives of ostomy pouch users across the globe. With distribution contracts in Europe and the US, and a strong pipeline of exciting new products, you will be joining a dynamic team in a company that is on a significant growth trajectory.

Job Description

In your role as Quality Engineer, you will report directly to the Chief Operating Officer, gaining exposure to company operations at an executive level, while supporting business growth and international expansion.

You will contribute to the success of the business as a key member in the Quality team supporting Ostoform’s key business functions such as R&D, Manufacturing, Purchasing and Sales. Daily activities that will include, but are not limited to, the following areas:

Quality Management System

  • Support in the planning and implementation of Ostoform’s strategies and procedures for quality management and product testing.
  • Responsibility of Document Controller to manage Ostoform’s QMS Document Control process
  • Support post-market surveillance activities, feedback and complaint logging and generation of KPI’s
  • Support the internal audit process & maintain accurate documentation

Design Validation & Verification

  • Product test design and development
  • Analysis of results and technical report writing
  • Support the implementation and population of design history files
  • Support the R&D team in technical file preparation and regulatory approvals

Supplier Management

  • Support the oversight of contract manufacturing organisation (CMO) with respect to compliance and quality control & incoming inspection of product.
  • Support supplier selection, approval and monitoring process .

Experience

The ideal candidate will have previously worked in the medical devices industry and will understand the medical device quality process, particularly relating to, MDR 2017-745, ISO13485 & FDA21 CFR 820  They should  possess good analytical and critical thinking skills, have excellent attention to detail & communication skills. They should have 3+ years of experience in relevant industry roles and a qualification to Level 8 or equivalent. 

For more information or to submit a CV, please contact:

eoghan.spain@ostoform.com