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
- Provide support to internal functions in the application, maintenance, and improvement of quality systems, procedures, and department-specific processes.
- 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.
- 3+ years of experience in GMP environments including knowledge of change management principles and industry standard QMS applications.
- Strong interpersonal teamwork and organizational as well as effective oral and written communication skills.
- May require domestic and international travel (5-10%)
