(Senior) Quality Engineer
Location: NetherlandsSIRE 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 organization, based in Zuid-Holland Netherlands.
ROLE DESCRIPTION
Optimize systems and processes that are aligned with Mentor’s strategy and mission effecting continuous quality improvement.
RESPONSIBILITIES
1. Supports, consults, trains on, and leads quality improvement projects throughout the life cycle of Mentor 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 pFMEA documentation and leading pFMEA 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 at The Netherlands Operations.
REQUIREMENTS
- University/Bachelor level in engineering or science
- Basic statistical analysis tools
- 5+ years relevant experience
- Of which 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
OTHER
• Pro Active
• Trouble shooting and Risk Assessment / Risk Management minded
• Tact
• High level of accuracy
• Flexible and Service minded
• Able to identify and simplify complex issues
• Communication skills
• Fluent in English, Dutch pre
Please note: Strongly theoretical role (reviewing documentation, identify gaps and solving these, making the company 'audit-proof'. This role is to prepare for new audit system to use next year.
Project based assignment (~10 months duration)
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.
