What are the responsibilities and job description for the Quality Engineer position at LanceSoft, Inc.?
Job Title : Manufacturing Quality Engineer
Location : San Diego, CA
Duration : 12 Months
Purpose of the role :
Provide Process / Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Provide Process / Quality Engineering support to product development teams, helping to ensure development of highest quality new products.
What You’ll Work On :
- Lead Risk Management activities including analyzing field data to support Failure Mode Effects Analysis and Hazard Analysis.
- Support Test and Inspection Method development including Method Validation activities.
- Support Design Verification and Design Validation planning and execution, including cross-functional root-cause analysis investigation and resolution activities.
- Maintain high standards for Device History File (DHF) content completion, integrity, and regulatory / standards compliance; collaboratively identifying, communicating, and resolving gaps.
- Writes and revises SOPs, controlled forms, and related documents to ensure best practices and maintain compliance.
- Own Corrective Action / Preventive Action (CAPA) investigations.
Required Qualifications :
Preferred Qualifications :
