61 QUALITY ASSURANCE LEAD Jobs in San Diego, CA
Wondfo USA is Hiring a QUALITY ASSURANCE LEAD Near San Diego, CA
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%)
Job Summary
Full Time
$132k-162k (estimate)
04/17/2024
06/16/2024
wondfousa.com
San Diego, CA
50 - 100
Related Companies
The job skills required for QUALITY ASSURANCE LEAD include Quality Assurance, Quality Control, Planning, Written Communication, Internal Audit, Standard Operating Procedures, etc. Having related job skills and expertise will give you an advantage when applying to be a QUALITY ASSURANCE LEAD. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by QUALITY ASSURANCE LEAD. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for QUALITY ASSURANCE LEAD positions, which can be used as a reference in future career path planning. As a QUALITY ASSURANCE LEAD, it can be promoted into senior positions as a Software Quality Assurance Director that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary QUALITY ASSURANCE LEAD. You can explore the career advancement for a QUALITY ASSURANCE LEAD below and select your interested title to get hiring information.
Similar Jobs
Popular Articles
