Quality Technician

About the role

This role leads investigational efforts at the Client’s Post Market Complaint Investigation Site (CIS), focusing on conducting investigations of returned products related to complaints, primarily on Capital Equipment (e.g., computer systems). Reviews return device data, completes investigation documentation and coding, and ensures conclusions align with testing results. Collaborates cross-functionally with teams such as Design Quality, R&D, Supplier Management, and Operations to support thorough analysis and risk understanding. Escalates product issues, drives continuous improvement, and reports findings.

Responsibilities

• Conduct independent failure analyses and document complaint findings.
• Utilize the Client’s testing tools and techniques to support root cause investigations.
• Identify patterns through data analysis, including manufacturing data review.
• Investigate and support resolution of Non-Conformances (NCEPs) and Corrective and Preventive Actions (CAPAs).
• Collaborate across departments to resolve product issues.
• Drive continuous improvement initiatives.
• Support lab operations and enhancements.

Requirements

• 2 years of experience with a high school degree, or an equivalent combination of education/work experience.

Qualifications

• 2 years of quality or manufacturing experience in the medical device industry.
• Post market experience ideal.
• Knowledge of Quality System Regulations, Medical Device Regulation, and ISO 13485 Quality Standards.
• Experience in the medical device industry or a Quality organization.
• Proficiency with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook.
• Ability to collaborate and influence across multiple, cross-functional teams.
• Knowledge of analytical techniques, problem solving, continuous improvement programs, and statistical analysis.
• Self-starter with the ability to identify improvement opportunities.
• SOP writing experience.