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

Job 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.

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) :

Quality Control (QC) – Product-Focused

Qualifications :

Preferred Qualifications :

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?

To Apply :

Please submit your resume and cover letter to Binbin.Su@ptncmed.com. We look forward to reviewing your application!

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