Quality Control Engineer (Irvine)

Job Title : Quality Control (QA / SQE / QC) Engineer

Location : Irvine, CA (On-site)

Job Overview :

We are seeking a highly motivated and detail-oriented Quality Control Engineer to join our team in Irvine, California. The ideal candidate will support Quality Assurance (QA), Supplier Quality Engineering (SQE), and Quality Control (QC) functions, ensuring compliance with ISO 13485 and FDA 21 CFR Part 820. This role plays a key part in maintaining product integrity and driving continuous improvement in manufacturing processes.

Key Responsibilities :

Quality Assurance (QA) Process / System-Focused

• Develop, implement, and maintain a compliant Quality Management System (QMS) per ISO 13485 and FDA 21 CFR Part 820.
• Lead internal and external audits; manage CAPA processes and follow-up activities.
• Conduct risk assessments (e.g., PFMEA) and ensure integration of quality into product development and manufacturing.
• Create, revise, and control SOPs, work instructions, forms, and quality records.
• Support equipment and process validations (IQ, OQ, PQ) for tubing manufacturing processes.
• Participate in customer audits and regulatory inspections.
• Collaborate with cross-functional teams (Engineering, Production, R&D) to define CTQ (Critical-to-Quality) parameters and ensure product quality.
• Maintain and organize Device History Records (DHRs), Device Master Records (DMRs), and training logs.

Supplier Quality Engineering (SQE) :

Quality Control (QC) Product-Focused

Qualifications :

Preferred Qualifications :