Quality Assurance/Supplier Quality Engineering/Quality Control - Irvine - Precision Tube & Catheter, Inc.

Description

About Us:

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 various applications, including anesthesiology, respiratory equipment, and biopharmaceutical laboratory equipment. Our commitment to innovation and excellence drives us to exceed industry standards and client expectations.

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Position Summary:

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 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.

Key Responsibilities:

Quality Assurance (QA) – Process/System-Focused

• 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.

Supplier Quality Engineering (SQE):

• 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.

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 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.

Qualifications:

• 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 Qualifications:

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

Working Conditions:

Work is performed in a manufacturing environment, requiring adherence to safety protocols.

May involve standing for extended periods and lifting materials as needed.

Benefits / Other:

We believe our employees are our greatest resource. We offer a competitive salary and benefits package including 401(k) with employer contribution, paid holidays, and vacation. Insurance coverage includes medical, dental, vision, and prescription drugs.We are proud to be an equal-opportunity workplace. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or Veteran status. If you have a disability or special need that requires accommodation, please let us know. If applying for positions in the U.S., you must be eligible to work in the U.S. without needing an employer-sponsored visa (work permit).

Why Join PT&C?

• Be part of a high-impact startup developing critical medical components.
• Work closely with founders and engineers to shape company processes and culture.
• Opportunity for rapid professional growth and ownership in building quality systems from the ground up.

To Apply:

Please submit your resume and cover letter to We look forward to reviewing your application

Precision Tube & Catheter, Inc. ( ) is an equal opportunity employer. xhmxlyz We celebrate diversity and are committed to creating an inclusive environment for all employees.