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