Quality EngineerBioTalent • Carlsbad, CA, US
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Quality Engineer
BioTalent • Carlsbad, CA, US
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job_description.job_card.job_descriptionBachelor's degree in Biomedical, Mechanical, Chemical, or related Engineering field 3+ 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
Join an innovative medical-device team focused on improving patient outcomes through engineering excellence and regulatory precision. The 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.
What You'll Do
- Develop 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.
What You'll Bring
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