What are the responsibilities and job description for the Quality Engineer – Complaint Focus position at BioTalent?
Quality Engineer – Complaint Focus
📍 Camarillo CA – United States
Must be authorized to work. No relocation US Citizen or Green Card holder
Join a growing medical device organization focused on quality, compliance, and continuous improvement. This role will play a key part in ensuring externally sourced materials, components, and services meet FDA, ISO, and internal quality standards.
Lead investigations into customer complaints, product defects, and manufacturing nonconformances, driving root cause analysis and implementing corrective actions. You’ll work cross-functionally with Manufacturing, Engineering, R&D, and Supply Chain to improve processes and prevent recurrence of quality issues.
🎯 What We’re Looking For
- Bachelor’s degree in Engineering, Life Sciences, or related field
- 5 years of experience in quality within pharma, biotech, or medical devices
- Experience leading CAPAs, nonconformances, change controls
- Experience in GMP or cleanroom environments
- Familiarity with ISO standards and regulatory requirements
- Experience with Lean / Six Sigma tools is highly preferred
- Excellent problem-solving, communication, and documentation skills
🔹 Ideal Background
Experience supporting medical device manufacturing, supplier oversight, validation activities (IQ/OQ/PQ), sterilization suppliers, and risk management processes.
🔑 What You’ll Do
- Lead investigations into customer complaints and product quality issues
- Perform root cause analysis and implement CAPA (Corrective and Preventive Actions)
- Conduct risk assessments and ensure timely resolution of quality events
- Collaborate with cross-functional teams to resolve manufacturing issues
- Support customer interactions, audits, and regulatory inspections
- Drive continuous improvement using Lean, Six Sigma, and quality tools
- Monitor quality trends and report performance metrics
- Maintain documentation and ensure compliance with GMP and ISO standards
🌟 Why Join Us?
- Work on impactful products in a regulated, high-quality environment
- Collaborate with cross-functional global teams
- Drive meaningful improvements in product quality and processes
- Grow your career in a dynamic and innovative organization
Work Authorization:
This role requires current authorization to work in the United States. We are unable to provide visa sponsorship now or in the future
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