Senior Quality Engineer - CONTRACT POSITIONBioTalent • Carlsbad, CA, US
Senior Quality Engineer - CONTRACT POSITION
BioTalent • Carlsbad, CA, US
2 days ago
Job type
- Full-time
Job descriptionDevelop and maintain quality controls, processes, and analytical methods to ensure conformance to product specifications. Lead verification and validation (V&V) testing, including protocol design, execution, data analysis, and reporting. Support design control activities and cross-functional reviews for new product development and significant design changes. Drive statistical analysis and data-driven decision making for process stability and product quality. Collaborate with manufacturing and suppliers to maintain conformance and improve assembly, testing, and documentation practices. Support supplier qualification , incoming inspection, and process improvement initiatives. Participate in risk management activities (ISO 14971) and ensure compliance with QMS and regulatory standards. Support internal and external audits (FDA, ISO), nonconformance investigations, and CAPA initiatives. Analyze field issues and deviations, perform root cause analysis, and implement effective corrective actions. Bachelor's degree in Biomedical, Mechanical, Chemical, or related Engineering field 3-5+ years of experience in a medical device quality engineering role. Working knowledge of FDA QSR, ISO 13485, ISO 14971 , and risk-based quality systems. Hands-on experience with verification testing, statistical analysis, and process validation Strong communication skills — able to produce clear reports, present findings, and collaborate across disciplines. Proficiency with Excel, Minitab, MATLAB , or equivalent analytical tools. Detail-oriented, organized, and proactive in driving continuous improvement.
NO C2C OR THIRD PARTIES
- Duration : 6-months with potential for extension
- Location : on-site 4x per week in Carlsbad, CA
- Hourly rate : $40-55 / hr DOE
Join an innovative medical-device team focused on improving patient outcomes through engineering excellence and regulatory precision. The Quality Engineer / Senior Quality Engineer will play a key role in ensuring compliance, reliability, and performance of life-changing technologies — supporting both product development and ongoing manufacturing operations.
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Senior Quality Engineer • Carlsbad, CA, US
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