Quality Assurance Lead

2 months ago


San Diego, United States Wondfo USA Full time

**JOB SUMMARY**

This position works directly with the Quality Systems Manager and Quality Assurance Associates toward the implementation of a Quality Management System in compliance with ISO 13485.

The Quality Assurance Lead will provide support in the implementation, maintenance, and improvement of company-wide Quality Management System procedures, and support processes. Proactively monitors the various elements of the QMS to help ensure compliance with quality system regulations and applicable national and international standards.

**RESPONSIBILITIES**
- Support the trending of quality systems such as deviation, change control, CAPA, complaints for management review processes.
- Lead or support quality functions such as supplier qualification and surveillance program.
- Lead or support internal audit programs including planning, implementation, report generation, corrective action issuance to closure.
- Writes new standard operating procedures or revises existing documentation utilizing document control systems.
- Creates and/or revises Quality Assurance documents such as gap analysis, risk assessment, reports to support compliance with regulatory requirements.
- Performs review of completed records from materials management, manufacturing, quality control, tech transfer etc.
- Provide support during regulatory inspections.
- Conduct local and global training on key elements of the QMS, including CAPA, Complaint, and Internal Audit. Execute projects and complete other duties as assigned.

**QUALIFICATIONS**
- Bachelor’s degree in biology, Engineering, or science-related field.
- 4+ years of Quality Assurance experience in the Biotech industry. Knowledge of ISO 13485, 14971 is preferred.
- Strong interpersonal teamwork and organizational as well as effective oral and written communication skills.
- May require domestic and international travel (5-10%)



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