SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Medical Devices organisation, based in Groningen Netherlands.

The Company

The company is the center of excellence for the development of innovative solutions for the surgical market. Mainly designing and manufacturing intraocular lenses. The site is responsible for the design and manufacture of these products. A project has started to support the integration of the company by supporting the harmonization of the validation activities therefore the quality department is looking for a Senior QA Engineer who will lead a cross-functional team to implement LIMS.

Role Description

You will be responsible for executing all Quality Assurance tasks that are within the responsibilities of the Quality Department. The primary tasks will be to lead a cross-functional team to implement LIMS in conformance with the site-specific needs. Part of this job is to understand the test methods, optimize the test method process flows and implement LIMS so that data can be efficiently managed. Also managing the change control process and the review and approval of validation documents is part of the responsibilities.

Responsibilities

- Execute all Quality Assurance tasks
- Lead a cross-functional team to implement LIMS
- Understanding and optimizing test methods and processes
- Managing the change control process
- Review and approval of validation documents

Requirements

- Master or Bachelors' Degree in a relevant field
- Minimum of 8 years' of experience in a medical device or pharmaceutical GMP environment
- Experience working with validation, change control and test methods (IQ/OQ/PQ)
- A high personal responsibility
- Able to work on multiple simultaneous tasks with limited supervision
- Able to work in an organized and accurate maner
- Quick learner, motivated self starter, hands-on
- Excellent customer service, interpersonal communication and team collaboration skills
- English spoken and written

Other information

The following experiences are a big plus:
- Experience with the leading and implementation of a LIMS project
- Familiarity with test method and software validation
- Dutch

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Helene de Vries.