You will manage quality management systems and validation activities within a regulated environment.
Responsibilities
Develop and implement standard operating procedures (SOPs) and Quality Management Systems (QMS) following ISO 13485, ISO 21, CFR part 820, and cGMP standards.
Create Process Flow Diagrams (PFD), Process Failure Mode Effect Analysis (PFMEA), and Quality Control plans.
Execute validation activities including IQ, OQ, PQ, and TQ.
Prepare Non-conformance Material Reports (NCMR).
Required Skills
5+ years of experience in quality engineering.
Master’s degree in Science, Technology, Computer Applications, or Engineering.
Proficiency in PFD development.
Experience with PFMEA.
Ability to design and implement Quality Control plans.
Knowledge of ISO 13485 and CFR part 820 compliance.
Experience with cGMP regulatory standards.
Hands-on experience with IQ/OQ/PQ/TQ validation protocols.