Quality AssuranceSupplier Quality EngineeringQuality Control Engineer

Position:
Quality Assurance / Supplier Quality Engineering / Quality Control Engineer

Location:

Irvine CA

We are a fast‑growing start‑up specializing in the manufacturing of high‑performance components for medical catheters including extruded tubing, shrink tubing and braided tubing. We are seeking a hands‑on and highly motivated Quality Assurance Supplier Quality Engineering and Quality Control (QA / SQE / QC) Engineer to lead and execute quality operations and help build a strong foundation for regulatory compliance and product excellence.

The QA / SQE / QC Engineer will play a critical role in establishing and maintaining product and process quality. This position will ensure that our products meet or exceed regulatory and customer expectations, support supplier quality management and oversee in‑house quality control activities.

• Develop and maintain a compliant Quality Management System (QMS) in accordance with 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 in product development and manufacturing.
• Write, revise and control SOPs, work instructions, forms and quality records.
• Support equipment and process validations (IQ, OQ, PQ) for tubing manufacturing processes.
• Participate in internal audits, customer audits and regulatory inspections.
• Manage CAPA processes: initiate, investigate and implement corrective and preventive actions.
• Collaborate with cross‑functional teams (Engineering, Production, R&D) to identify critical‑to‑quality (CTQ) parameters and ensure product quality.
• Maintain and organize Device History Records (DHRs), Device Master Records (DMRs) and training logs.

• Qualify and onboard new suppliers; perform supplier audits and evaluations.
• Define incoming inspection requirements and ensure component conformance.
• Manage supplier non‑conformances; initiate and follow through on SCARs.
• Collaborate with suppliers on process improvements and corrective actions.

• Perform incoming, in‑process and final inspections of extruded, shrink and braided tubing.
• Conduct First Article Inspections (FAIs) and maintain inspection records.
• Develop test methods and protocols for product performance and reliability.
• Monitor production quality metrics (e.g. scrap rate, yield, defect rate).
• Maintain and calibrate inspection tools and equipment.
• Use precision measurement tools (micrometers, laser micrometers, pin gauges, tensile testers, etc.).
• Monitor visual and dimensional quality to ensure conformance to specifications and customer requirements.
• Initiate and track Non‑Conformance Reports (NCRs) and assist in root‑cause analysis.
• Maintain calibration logs and ensure metrology equipment is accurate and up‑to‑date.

• Bachelor’s degree in Materials Engineering, Quality or a related technical field.
• 2 years of experience in a QA / SQE / QC role in the medical device industry preferred.
• Familiarity with catheter manufacturing processes, especially extrusion, shrink tubing or braiding is a strong plus.
• Solid understanding of ISO 13485 and FDA QSR (21 CFR Part 820) requirements.
• Experience with quality tools: CAPA, FMEA, 5 Whys, Fishbone Diagram, etc.
• Strong attention to detail, documentation and organizational skills.
• Hands‑on experience with inspection techniques and equipment.
• Ability to thrive in a fast‑paced startup environment.
• Excellent communication, problem‑solving and analytical skills.

• Experience with catheter manufacturing processes.
• ASQ certification (CQE, CQA or equivalent) is a plus.

Mandarin speaking is a plus.

Vacancy: 1