BioTalent
***********************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 Bachelor’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.
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 Bachelor’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.