NL-Leiden: Quality Assurance Engineer
To see other opportunities,
please visit http://sqa.fyicenter.com
Quality Assurance Engineer
- Utilize statistical tools and techniques to establish sampling plans. Supports engineering activities in process and vendor specification development.
- Lead and support validation activities (IQ, OQ, PQ)
- Analyzes process-, product-, test- and Quality Management System data and investigates for improvement opportunities.
- Develops quality plans, designs and implements experiments for process and product improvement and validation.
- Investigate instances of nonconforming material and facilitate the determination of cause, corrective action and recommendation of the disposition of product.
- Lead or support and 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.
- Requires a minimum of 3 years related experience within Pharmaceutical/Medical Device regulated environment.
- Mathematical and extensive knowledge in Statistics Skills are required.
- Computer Skills such as knowledge in software as Microsoft Excel, Power Point, etc is required
- ASQ Certification (CQE, CQA) desirable
To apply for this position, please visit
Team SQAFYI - Software QA Resource FYI