QUALITY ENGINEER II / CAPA ADMINSTRATOR Second Sight Medical Products

Job Description: 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 system. Maintains EtQ database of CAPA information. Analyzes CAPA data and develops and distributes monthly reports. Communicate regularly with assigned individuals/teams responsible for CAPA investigation, closure and verification of effectiveness. Tracks timeliness of CAPA activities. Schedules and Chairs the CAPA Committee meetings. Backfills for Quality Engineers are required. Minimum Work Experience: 3-5 years medical device experience or in a highly regulated industry. Working knowledge of quality systems requirements. Higher education in related discipline may be considered in lieu of experience. Minimum Education & Training: Minimum Bachelors Degree in Engineering Science or related field. Professional experience may be considered in lieu of education. Ability to read, understand, and execute quality procedures. Knowledge of GMP and ISO requirements. Knowledgeable with the principles of root cause analyses, validation and verification. Good interpersonal skills. Effective written and oral communication skills. Must be proficient in web-based and Microsoft Office applications. Strong Excel and Word skills.

Location:	Sylmar United States