Quality Technician III

About the role

The Quality Technician III supports the Cardiac Ablation Solutions organization, focusing on the check-in, inspection, and testing of returned product as part of the complaint handling process.

Responsibilities

• Manage inventories of devices inside the lab, including shipping and handling packages.
• Follow testing work instructions and document findings.
• Research, resolve, and respond to discrepant receipts from internal/external customers.
• Support complaint Product Analysis and investigations with limited supervision.
• Interact with co-workers to facilitate the sharing of information and timely resolution to complaint investigations.
• Use inspection and testing equipment and generate summary reports supporting the analysis results.
• Execute product Inspection and test plans on bio-hazard product.
• Identify failures, potential causes, and capture the supporting objective evidence.
• Label, package, and deliver inventories to the analysis lab.
• Generate product analysis reports.
• Provide support with the development of procedures, processes, tools, and techniques for performing product analysis.

Requirements

Required: High School diploma. Minimum of 4+ years of relevant work experience and may require vocational or technical education or certification in addition to prior work experience.

Qualifications

• Nice to have: Medical device industry experience.
• Familiarity with these regulations: FDA 21 CFR Part 820, EU 217/745 (EU MDR).
• Familiarity with these standards: ISO 13485, ISO 14971, IEC 60601.
• Knowledge of Microsoft Office Applications (Word, Excel, Access, and PowerPoint) and Windows OS.
• Strong written and verbal communication and organization skills, and ability to work cooperatively as part of a cross-functional team.