Job Description
Job Description
The Quality Assurance Technician ensures that all extruded medical tubing and secondary operations meet strict quality, regulatory, and customer requirements. Working within an ISO 13485 and FDA-compliant manufacturing environment, this role is responsible for performing inspections, testing, and documentation to support the consistent production of safe, high-quality medical devices.
Key Responsibilities:
- Perform incoming, in-process and final inspections on tubing and components using precision measurement tools (micrometers, calipers, laser gauges, optical comparators, vision systems etc.).
- Verify products meet engineering drawings, specifications, and regulatory requirements.
- Conduct functional and dimensional testing according to approved procedures and with the appropriate sampling plan(s).
- Document inspection results accurately in accordance with Good Documentation Practices (cGDP).
- Monitor extrusion processes and collaborate with operators to address quality issues in real time.
- Assist with nonconformance investigations, root cause analysis, and corrective/preventive actions (CAPA).
- Maintain calibration of measurement equipment in compliance with internal schedules.
- Ensure adherence to ISO 13485 and FDA QSR requirements in all quality activities.
- Support lot traceability through proper labeling, material control, and recordkeeping.
- Participate in internal audits and readiness activities for third-party and regulatory inspections.
- Identify opportunities for process improvement to enhance quality and reduce scrap.
Qualifications:
Required:
- High school diploma or equivalent; technical training in quality, manufacturing, or a related field preferred.
- 1-3 years of quality assurance or inspection experience in a manufacturing environment.
- Proficiency in using precision measurement instruments.
- Basic understanding of ISO 13485 and FDA 21 CFR Part 820 requirements.
- Strong attention to detail, organizational skills, and documentation accuracy.
- Ability to read and interpret technical drawings and specifications.
- Effective communication skills and ability to work collaboratively across departments.
- Basic computer skills, including MS Office and ERP/MES systems.
Preferred:
- Experience in medical device manufacturing, especially polymer extrusion or tubing production.
- Familiarity with statistical process control (SPC) and quality tools.
- Knowledge of GMP and GDP best practices.
- Internal Audits
Work Environment: This position is performed in a manufacturing environment with regular exposure to extrusion processes and inspection laboratories. PPE is required. The role involves standing, walking, and performing precise measurement tasks for extended period