Quality Assurance​/Supplier Quality Engineering​/Quality Control; QA​/SQE​/QC Engineer

Quality Assurance/Supplier Quality Engineering/Quality Control (QA/SQE/QC) Engineer

Precision Tube & Catheter, Inc. (PT&C) is a high‑tech enterprise dedicated to manufacturing advanced materials and components for interventional and implantable medical devices. We produce high‑quality medical tubes used in anesthesiology, respiratory equipment, and biopharmaceutical laboratory equipment. Our commitment to innovation and excellence drives us to exceed industry standards and client expectations.

We are a fast‑growing startup specializing in the manufacturing of high‑performance components for medical catheters, including extruded tubing, shrink tubing, and braided tubing. We seek a hands‑on, highly motivated 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, ensuring our products meet or exceed regulatory and customer expectations, supporting supplier quality management, and overseeing 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.
• Collaborate with cross‑functional teams (Engineering, Production, R&D) to identify critical‑to‑quality 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.
• 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.

Work is performed in a manufacturing environment, requiring adherence to safety protocols. The role may involve standing for extended periods and lifting materials as needed.

We believe our employees are our greatest resource.…