Job Description
An employer is looking for a Quality Assurance Engineer to join their team. The employer is an enterprise level company in the biotech industry. This QE will own the quality and validation of a next-generation sequencing product line in Carlsbad, CA. Responsibilities will include:
· Collaborate across function, leveraging quality and manufacturing expertise to troubleshoot problems, interpret data, and determine next steps
· Manage problem requests (nonconformances), complaint records, and corrective and preventive actions (CAPAs)
· Risk management & equipment validation
· Non-Conformance Reporting (NCR)
· Participate in change control activities for documents and manufacturing processes
· Assist with the maintenance of ISO registration and the internal audit program
· Ensure proper use of quality systems and processes
· Provide guidance and direction to ensure ISO/Quality system compliance
· Manage maintenance, completeness, and accuracy of Quality records
· Perform training on Quality procedures
· Create, review and revise quality policies and procedures
· Collect and analyze quality data and make recommendation of corrective actions
· Product complaint management & investigations
Requirements:
· Bachelor’s Degree
· 5 years’ experience in Quality Engineering/Assurance
· Experience in a manufacturing or production environment
· Regulated industry experience (biotechnology, life sciences, medical device, pharmaceutical)
· ISO 9001 & ISO 13485 experience