Intermediate understanding of procedures.

Troubleshoots basic issues.

Manages consumables and work area.

Shares knowledge with peers.

Receives a moderate level of guidance and direction.

Experience applying QMS procedures in daily tasks and audits.

Working knowledge of GMP principles in medical device manufacturing.

Proficient in product testing and inspection methodologies.

Practical use of statistical methods, process control, and quality tools (e.g., Six Sigma, DOE, FMEA).

Experience using risk management documentation (e.g., ISO 14971) for risk mitigation and change management.

Active participation in CAPA investigations and implementation of corrective/preventive actions.

Learning FDA regulations (21 CFR Part 820) ...