Precision Tube & Catheter, Inc. · 1 month ago
Quality Assurance/Supplier Quality Engineering/Quality Control (QA/SQE/QC) Engineer
Irvine, CA
Full-time
Onsite
Entry, Mid Level
2+ years expPrecision Tube & Catheter, Inc. is a high-tech enterprise dedicated to manufacturing advanced materials and components for interventional and implantable medical devices. They are seeking a hands-on and highly motivated Quality Assurance/Supplier Quality Engineering/Quality Control Engineer to lead and execute quality operations, ensuring that products meet or exceed regulatory and customer expectations while supporting supplier quality management.
Medical Device
No H1B
Hiring Manager
Icey Liu
Responsibilities
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
Qualification
Required
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
Preferred
Experience with catheter manufacturing processes
ASQ certification (CQE, CQA, or equivalent) is a plus
Mandarin speaking is a plus
Benefits
401(k) with employer contribution
Paid holidays
Vacation
Insurance coverage includes medical, dental, vision, and prescription drugs.
Company
Precision Tube & Catheter, Inc.
http://www.ptncmed.com
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase