Sr Technician, Quality (Product Evaluation Lab)

Terumo Neuro; Aliso Viejo, Northern (CA, KY); Hybrid; USD 49,000 - 64,000; Full time

Job summary

Terumo Neuro in California is seeking a Sr Technician, Quality to support QA activities for development and manufacture of medical devices. You will work with engineers to address product reliability and quality issues and assist with testing, CAPA, audits, and process improvements.

Responsibilities include documenting post-market quality issues, assisting with MDR/Vigilance compliance, and coordinating with the Lab Coordinator on returns and data entry.

Responsibilities

• Product evaluation, investigation, and documentation of post-market product quality issues relating to customer complaints.
• Investigation and evaluation of products relating to reportable complaints (e.g. MDR, Vigilance, etc.), including documentation.
• Assist engineers with investigation of product and process quality issues.
• Assist engineers with product testing and test method development and validation.
• Assist with activities related to equipment calibration, corrective/preventive actions, nonconformance reports, internal audits, and CAPA projects.
• Assist Lab Coordinator with receiving, decontaminate product returns in-house, and input into database.
• Operate X-Ray Machine (certification required).
• General complaint handling and investigation process improvement.

Job description

Sr Technician, Quality (Product Evaluation Lab)

Position Overview

Support the quality assurance activities related to development and manufacture of medical devices. Work with engineers to investigate and address various product reliability and quality issues.

Job duties:

• Product evaluation, investigation, and documentation of post-market product quality issues relating to customer complaints.
• Investigation and evaluation of products relating to reportable complaints (e.g. MDR, Vigilance, etc.), including documentation.
• Assist engineers with investigation of product and process quality issues.
• Assist engineers with product testing and test method development and validation.
• Assist with activities related to equipment calibration, corrective/preventive actions, nonconformance reports, internal audits, and CAPA projects.
• Assist Lab Coordinator with receiving, decontaminate product returns in-house, and input into database.
• Operate X-Ray Machine (certification required).
• General complaint handling and investigation process improvement.
• Perform additional duties as assigned.

Job ID 14271BR

Salary Range:

$23.51/Hour - $30.86/Hour (Financial compensation packages may be higher/lower than listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand)