Quality Technician

Quality Technician

This position supports complaint investigations for manufactured and marketed medical devices. The Quality Technician will catalog returned products associated with registered complaints, photograph devices in their "as received" condition, decontaminate used devices, and document the initial visual assessment in the complaint database. This role works closely with Quality Engineers to support the investigation process.

Essential Duties & Responsibilities

• Must be willing to work with used, potentially contaminated medical devices.
• Ensure proper documentation and registration of returned complaint devices.
• Prepare clear and effective reports based on the initial investigation of returned devices.
• Perform basic troubleshooting and root cause analysis.
• Communicate effectively and professionally with internal and external customers, as required.
• Conduct basic product testing, including leak tests, flow tests, and basic measurements.
• Work closely with Quality Engineers to support investigations of returned devices.
• Follow current Good Manufacturing Practices (cGMP).
• Maintain a high level of organization and attention to detail.
• Perform additional duties and special projects as assigned.

Knowledge, Skills & Qualifications

• Ability to read and interpret product specifications and test procedures.
• Knowledge of cGMP requirements.
• Basic math skills.
• Proficiency in Microsoft Office; experience with TrackWise is a plus.
• Strong verbal and written communication skills.

Education & Experience

• High School Diploma or equivalent required.
• Minimum of 2 years of experience in a similar quality role within the medical device industry.

Minimum Qualifications

• Must be at least 18 years of age.