Quality Engineer/CAPA and EtQ Administrator Second Sight Medical Products
Administers the CAPA system. Facilitates CAPA movement through processing phases. Ensures
adequate documentation for CAPAs as they are closed. Provides metrics that enable management to
gage the effectiveness of this system.
Develops, implements and maintains quality engineering systems and practices which meet Second Sight
quality and regulatory requirements. In this capacity you will serve to improve awareness, visibility,
compliance and communication on quality initiatives to support departmental, functional, and company
quality goals. Provides focused quality engineering support within the product development,
manufacturing and quality control. Configure, implement and maintain the QMS application modules in
EtQ quality management software. Ensure that SSMP documents and document control records
complies with Document Control policies and procedures.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
? Responsible for the administration of the Corrective and Preventive Action (CAPA) process.
? Works with staff to administer and expedite disposition of identified issues through the CAPA
? Analyzes CAPA data and develops and distributes monthly reports. Communicates CAPA status
to senior management
? Communicates regularly with assigned individuals/teams responsible for CAPA investigation,
closure and verification of effectiveness.
? Tracks timeliness of CAPA activities and maintains database of CAPA information
? Provides back-end support for EtQ and trains new EtQ users.
? Modifies, improves and validates EtQ workflows as required.
? Identify non-conformance trends and opportunities for quality improvements.
? Proactively investigate and implement quality engineering practices to resolve non conformances
and quality issues.
? Assure the development and execution of the EtQ Quality management system.
? Responsible for Document Control and Training systems, and serves as back-up to the
training/document control specialist.
? Supports Manufacturing needs for calibration and preventative maintenance system.
? Verifies that CER monitoring and maintenance are completed as required.
? Responsible for impact assessments when equipment/facilities are found to be out of
? Supports Regulatory body audits, both in preparation and interaction with auditors
? Backfills for other Quality Engineers as required.
EDUCATION: Bachelor?s Degree in Engineering Science or related field. Higher education in related
discipline may be considered in lieu of experience
EXPERIENCE REQUIRED: 3-5 years medical device experience or in highly regulated industry.
? Working knowledge of quality systems requirements.
? Knowledge of GMP and ISO requirements
? Knowledgeable with the principles of root cause analyses, validation and verification.
? Knowledge of CAPA principles and required closure requisites.
? Ability to read, understand, and execute quality procedures.
? Good Interpersonal skills
? Effective written and oral communication skills.
? Must be proficient in web-based and Microsoft Office applications. Strong Excel and Word skills.
? Must be proficient in EtQ application and transaction processes.
||12744 San Fernando Road |
Sylmar, CA 91342