Description

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.

Key Skills

Education

Any Graduate