Vacancy caducado!
- Capable of authoring and executing process validations (IQ, OQ, PQ) in accordance with QSR, FDA and international procedures including data analysis through statistical methods.
- Perform risk assessment activities to identify product quality or compliance risks and lead efforts to mitigate those risks including PFMECA updates and escalation of Design Document changes as needed.
- Skillfully utilizes problem solving tools to analyze and identify root cause and to implement corrective actions.
- Makes decisions and proposes solutions based on calculated risks.
- Originate and complete changes and change orders in compliance with Quality System Regulation (QSR 21 CFR 820), ISO 13485:2016, Danvers Quality Business System, and Corporate Policies.
- Bachelor's degree in engineering discipline
- 5+ years Manufacturing Engineering experience in a GMP environment or highly regulated industry with a BS degree. 2+ years with a Master's degree
- 5+ years of Manufacturing Engineering experience in a QSR (GMP) medical device environment
- Demonstrated working knowledge of process validation, statistical methods, risk management
- Knowledge of EU MDR Requirements
Vacancy caducado!