Summary:

The Quality Engineer applies engineering principles to ensure product and process compliance with internal and external quality standards. This role focuses on managing CAPA and NCR processes, performing receiving inspections, and supporting quality system activities to drive continuous improvement and regulatory compliance.

Job Responsibilities:

* CAPA Management: Lead and support Corrective and Preventive Action (CAPA) investigations, including root cause analysis, action implementation, and effectiveness verification.

*Nonconformance (NCR) Handling: Review and process NCRs, coordinate cross-functional resolution efforts, and ensure timely closure in compliance with quality procedures.

*Receiving Inspection: Perform inspections of incoming materials and components to verify conformance to specifications and regulatory requirements. Maintain inspection records and collaborate with suppliers on quality issues.

*Quality System Support: Assist in internal and external audits, maintain documentation for ISO 13485 and FDA QSR compliance, and support quality system improvements.

*Data Analysis & Reporting: Analyze quality data, prepare reports on trends and metrics, and recommend improvements to enhance product quality and process efficiency.

Skills:

* Strong analytical and problem-solving skills.

*Excellent verbal and written communication.

*Ability to read and interpret engineering drawings, blueprints, and technical documentation.

*Proficiency in quality tools such as FMEA and root cause analysis.

*Experience with quality software systems and inspection tools.

*Team-oriented with attention to detail.

Education/Experience:

* Bachelor's degree in engineering required.

* 2-4 years experience required.

*Familiarity with CAPA, NCR, receiving inspection, and regulatory compliance standards.

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county, to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.