Reports to: VP QA and Regulatory Affairs
Salary: $70k-$75
Job Summary: The Quality Assurance Supervisor is responsible for all quality related activities within the organization, including but not limited to inspection, supplier management, CAR/PAR and audits and is required to maintain our continued ISO Compliance.
Essential Functions:
Work closely with suppliers, customers and other departments to meet quality needs.
Manage customer complaint system including adverse event reporting, root cause analysis, and customer correspondence.
Develop, establish and implement quality policies and procedures, inspection plans, quality performance trends and continuous improvement initiatives and complete inspection forms to assure specifications and tolerance are met.
Direct completion of inspection activities based on inventory, equipment and personnel requirements.
Review inspection data, address non-conforming materials issues and consistent follow up with vendors and engineering to evaluate root cause of non conformity.
Follow up with suppliers for non-conforming materials and completion of corrective action plans.
Evaluate suppliers quality systems overseeing site audits and manufacturing process capabilities.
Maintain approved supplier list and quality test results in conjunction with supply chain.
Participate in design control activities with engineering to identify quality related issues during the design phases of device development and device modification
Manage corrective/preventive action system. Follow up with CAR/PAR responses from all sources and track corrective action activities from all sources.
Direct internal audit activities and scheduled completion.
Participate in third party audits/assessments, recommend and manage external audits.
Interface/coordinate with customer to address/resolve quality issues and concerns relative to quality performance, investigation, system audits and corrective actions.
Participate in professional organization, symposiums and continuing education that will promote and benefit company.
Educational/Experience Requirements:
Experience and knowledge of ISO 13485, FDA, MDD
Minimum 7 years experience in Quality/Regulatory, knowledge of regulatory standards.
Experience with manufacturing clean room environment.
Bachelors degree or equivalent.
Excellent written and verbal communication skills.
Must be able to lift 20 pounds.
- Location: Los Angeles, 90016
- Compensation: $70,000 - $75,000
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