Senior QA Technician

Endovascular Engineering•Menlo Park, CA

17d•Onsite

About The Position

The QA Technician inspects incoming raw materials and manufactured products, including quality control inspections and lot-release testing. This onsite role is part of a small team working in a fast-paced, cutting-edge environment to bring new products and processes into reality. The position also supports quality processes, production and materials coordination, and engineering projects.

Requirements

At least 6 years of relevant experience in the medical device industry.
Experience in an ISO 13485 or medical device production environment.
Experience with measuring devices such as calipers and micrometers.
High school diploma.
Ability to adhere to established specifications, procedures, and policies during inspections.
Excellent computer skills, including effective use of Microsoft Excel and Word.
Understanding of Quality Systems, Good Manufacturing Practices, and Good Documentation Practices.

Responsibilities

Conduct incoming, in-process, and final quality inspections using appropriate equipment and techniques.
Conduct statistical analysis on select processes and report findings.
Assist with problem solving, root cause analysis, and corrective actions.
Maintain accurate documentation of quality inspection results.
Ensure incoming materials comply with required specifications.
Perform final product release, ensuring outgoing products comply with required specifications and that the Device History Record (DHR) is complete.
Ensure equipment is current for calibration and preventive maintenance.
Assist in developing and maintaining quality procedures and work instructions.
Collaborate with Materials and Production resources to ensure inventory needs are met.
Administer and escalate issues involving non-conforming material.
Support the Engineering team with projects as needed.