BioTalent
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
$165,000.00/yr - $210,000.00/yr Direct message the job poster from BioTalent Quality Engineering Manager – Catheter Products
Onsite Role - 5 Days a week Location:
SF Bay Area - East Bay Compensation:
$165,000 – $210,000 Type:
On-site Overview
We are seeking a Quality Engineering Manager to lead a team of 3–5 engineers supporting catheter product manufacturing. This role drives the development, implementation, and continuous improvement of quality engineering functions while ensuring compliance with FDA QSR, ISO standards, and global regulations. Key Responsibilities
Manage quality engineering, supplier management, calibration, environmental monitoring, and inspection functions Lead and mentor engineers supporting development, inspection, and manufacturing activities Ensure compliance with QMS, FDA QSR, ISO, and international requirements Support audits and inspections by regulatory agencies and notified bodies Drive process validation, test method development, statistical analysis, and improvement projects Collaborate on CAPAs, non-conformances, and risk management activities Qualifications
Bachelor’s degree in Engineering, Quality, or Life/Physical Sciences (advanced degree preferred) 4+ years of relevant experience in quality, engineering, or regulated industries (medical device preferred) Strong knowledge of FDA QSR, ISO standards, sterilization, biocompatibility, and process validation Hands-on experience with SPC, CAPA, DOE, statistical sampling, and test method validation Excellent communication, leadership, and technical writing skills CAD and Microsoft Office proficiency Working Conditions
Office, lab, and cleanroom environments Limited travel (0–10%) Ability to lift up to 25 lbs and support inspections, audits, and testing Referrals increase your chances of interviewing at BioTalent by 2x Get notified about new Quality Engineering Manager jobs in
San Francisco Bay Area .
#J-18808-Ljbffr
$165,000.00/yr - $210,000.00/yr Direct message the job poster from BioTalent Quality Engineering Manager – Catheter Products
Onsite Role - 5 Days a week Location:
SF Bay Area - East Bay Compensation:
$165,000 – $210,000 Type:
On-site Overview
We are seeking a Quality Engineering Manager to lead a team of 3–5 engineers supporting catheter product manufacturing. This role drives the development, implementation, and continuous improvement of quality engineering functions while ensuring compliance with FDA QSR, ISO standards, and global regulations. Key Responsibilities
Manage quality engineering, supplier management, calibration, environmental monitoring, and inspection functions Lead and mentor engineers supporting development, inspection, and manufacturing activities Ensure compliance with QMS, FDA QSR, ISO, and international requirements Support audits and inspections by regulatory agencies and notified bodies Drive process validation, test method development, statistical analysis, and improvement projects Collaborate on CAPAs, non-conformances, and risk management activities Qualifications
Bachelor’s degree in Engineering, Quality, or Life/Physical Sciences (advanced degree preferred) 4+ years of relevant experience in quality, engineering, or regulated industries (medical device preferred) Strong knowledge of FDA QSR, ISO standards, sterilization, biocompatibility, and process validation Hands-on experience with SPC, CAPA, DOE, statistical sampling, and test method validation Excellent communication, leadership, and technical writing skills CAD and Microsoft Office proficiency Working Conditions
Office, lab, and cleanroom environments Limited travel (0–10%) Ability to lift up to 25 lbs and support inspections, audits, and testing Referrals increase your chances of interviewing at BioTalent by 2x Get notified about new Quality Engineering Manager jobs in
San Francisco Bay Area .
#J-18808-Ljbffr