BioTalent
Senior Quality Engineer - CONTRACT POSITION
BioTalent, Carlsbad, California, United States, 92002
Senior Quality Engineer – CONTRACT POSITION
This range is provided by BioTalent. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base Pay Range $40.00/hr - $55.00/hr
NO C2C OR THIRD PARTIES
Duration: 6‑months with potential for extension
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.
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.
3‑5+ 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.
Seniority Level Mid‑Senior level
Employment Type Contract
Job Function Quality Assurance and Engineering
Industries Medical Equipment Manufacturing
Referrals increase your chances of interviewing at BioTalent by 2x.
Get notified about new Quality Engineer jobs in Carlsbad, CA.
#J-18808-Ljbffr
Base Pay Range $40.00/hr - $55.00/hr
NO C2C OR THIRD PARTIES
Duration: 6‑months with potential for extension
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.
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.
3‑5+ 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.
Seniority Level Mid‑Senior level
Employment Type Contract
Job Function Quality Assurance and Engineering
Industries Medical Equipment Manufacturing
Referrals increase your chances of interviewing at BioTalent by 2x.
Get notified about new Quality Engineer jobs in Carlsbad, CA.
#J-18808-Ljbffr