Job Details

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):

• Qualify and onboard new suppliers; conduct supplier audits and evaluations.
• Define incoming inspection requirements to ensure component conformance.
• Manage supplier non-conformances and issue Supplier Corrective Action Requests (SCARs).
• Partner with suppliers to drive process improvements and implement corrective actions.

Quality Control (QC) – Product-Focused

• Perform incoming, in-process, and final inspections of extruded, shrink, and braided tubing.
• Conduct First Article Inspections (FAIs) and maintain accurate inspection records.
• Develop and execute test methods and protocols for product performance and reliability.
• Track and analyze production quality metrics (scrap rate, yield, defect rate).
• Calibrate and maintain inspection tools and metrology equipment.
• Utilize precision tools such as micrometers, laser micrometers, pin gauges, tensile testers, etc.
• Ensure visual and dimensional quality meets specifications and customer requirements.
• Initiate and manage Non-Conformance Reports (NCRs) and assist in root cause analysis.
• Maintain calibration logs to ensure all inspection instruments are current and accurate.

Qualifications:

• Bachelor's degree in Materials Engineering, Quality, Mechanical, or a related technical field.
• 2+ years of experience in QA/SQE/QC roles within the medical device industry (preferred).
• Familiarity with catheter manufacturing processes (extrusion, shrink tubing, or braiding) strongly preferred.
• Solid understanding of ISO 13485 and FDA QSR (21 CFR Part 820) requirements.
• Proficiency with quality tools such as CAPA, FMEA, 5 Whys, and Fishbone Diagrams.
• Strong attention to detail, documentation, and organizational skills.
• Hands-on experience with inspection techniques and measurement equipment.
• Ability to excel in a fast-paced, startup environment.
• Excellent communication, analytical, and problem-solving skills.

Preferred Qualifications:

• Experience in catheter manufacturing processes.
• ASQ certification (CQE, CQA, or equivalent).
• Mandarin language proficiency is a plus.