Quality Engineer

Location: Netherlands

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science 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!

THE COMPANY

Our client is a professional Medical Devices and Pharmaceutical organization, based in Zuid-Holland Netherlands.

You will be working for a multinational which seeks to positively impact human health through innovation. They do this by helping entrepreneurs realise their dreams of creating healthcare solutions that improve peoples’ lives around the world. Our client also works side-by-side with innovators throughout their journey, providing a robust exchange of ideas and resources to support their success.

ROLE DESCRIPTION

As Quality Engineer you will be optimising systems and processes that are aligned with the strategy and mission effecting continuous quality improvement and ensuring compliance of the Quality Management system. This role is to prepare for new audit system to use next year. Project based assignment (~10 months duration)

Please note: Strongly theoretical role (reviewing documentation, identify gaps and solving these, making the company 'audit-proof'.

RESPONSIBILITIES

1. Supports, consults, trains on, and leads quality improvement projects throughout the life cycle of different products this includes product design and
development, manufacturing, purchasing and improvements.
2. Utilize statistical tools and techniques to establish sampling plans. Supports engineering activities in process and vendor specification development.
3. Analyzes process-, product-, test- and Quality Management System data and investigates for improvement opportunities.
4. Responsible for documentation and leading meetings.
5. Reviews validations documentation (eg. IQ, OQ, PQ and verification studies).
6. Leads or is team member of CAPA investigation and action plans.
7. Leads or is team member of Internal audit observation investigation and action plans.
8. Investigate instances of nonconforming material and supports the determination of cause, corrective action and recommendation of the disposition of
product.
9. Ensures that software validations are performed according to applicable FDA guidelines. Provides end user support by software validation throughout
the Software Validation Life Cycle.

REQUIREMENTS

- University/Bachelor level in engineering or science
- Basic statistical analysis tools
- 5+ years relevant experience including 3+ years with Pharmaceutical/Medical Device companies
- Knowledge of software and process validations
- Knowledge in Statistics
- Sufficient knowledge about computer systems and programming with Crystal Reports

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Rowin van der Zwaan.