Description
Essential Duties:- 5+ years recent experience product, process, equipment validation within a medical device company.
- Ability to analyse and interpret data.
- Good interpersonal and organisational skills.
- Proficient computer skills (MS Office etc)
- Degree qualified - Science/Engineering
Desired Minimum Qualifications/Experience:
- FDA Validation requirements & understanding.
- Software Validation requirements.
- Development IQ/OQ and PQ protocols.
- Performance of qualification activities.
- Report Writing.
- Process FMEA.
- Risk Management.
- SOP/specification development.
- Document/Change control.
- CAPA
If you are interested or know anyone who might be, please contact Sarah Irvine on .