Brightpath Associates LLC
Brightpath Associates LLC provided pay range
This range is provided by Brightpath Associates LLC. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $140,000.00/yr - $150,000.00/yr
Direct message the job poster from Brightpath Associates LLC
The Sr. Quality Engineer will implement and maintain FDA QSR (21 CFR 820) and ISO 13485 quality systems for the CellFX System and related medical devices, supporting R&D, manufacturing, regulatory, and clinical teams.
Key Responsibilities
Provide quality and compliance guidance for product design and manufacturing.
Develop and maintain quality systems, risk management (ISO 14971), and traceability documentation.
Manage biocompatibility (ISO 10993) and sterilization (ISO 11135/11137) testing.
Implement process controls, conduct statistical analyses, and support MRB activities.
Review quality performance data and assist in labeling, UDI, and regulatory submissions.
Support audits (FDA, Notified Body, MDSAP) and management reviews.
Qualifications
BS in Engineering, Science, or related field; 5+ years of quality experience in Class II/III medical devices (cardiovascular preferred).
Deep knowledge of FDA QSR, ISO 13485, MDR, ISO 14971, ISO 10993, and related standards.
Experience from product development to commercialization.
Strong analytical, communication, and problem-solving skills.
Proficient in Microsoft Office; able to travel up to 10%.
Seniority level Not Applicable
Employment type Full-time
Job function
Quality Assurance
Medical Equipment Manufacturing
Additional Notes Referrals increase your chances of interviewing at Brightpath Associates LLC by 2x.
Get notified about new Quality Engineer jobs in
Hayward, CA .
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Base pay range $140,000.00/yr - $150,000.00/yr
Direct message the job poster from Brightpath Associates LLC
The Sr. Quality Engineer will implement and maintain FDA QSR (21 CFR 820) and ISO 13485 quality systems for the CellFX System and related medical devices, supporting R&D, manufacturing, regulatory, and clinical teams.
Key Responsibilities
Provide quality and compliance guidance for product design and manufacturing.
Develop and maintain quality systems, risk management (ISO 14971), and traceability documentation.
Manage biocompatibility (ISO 10993) and sterilization (ISO 11135/11137) testing.
Implement process controls, conduct statistical analyses, and support MRB activities.
Review quality performance data and assist in labeling, UDI, and regulatory submissions.
Support audits (FDA, Notified Body, MDSAP) and management reviews.
Qualifications
BS in Engineering, Science, or related field; 5+ years of quality experience in Class II/III medical devices (cardiovascular preferred).
Deep knowledge of FDA QSR, ISO 13485, MDR, ISO 14971, ISO 10993, and related standards.
Experience from product development to commercialization.
Strong analytical, communication, and problem-solving skills.
Proficient in Microsoft Office; able to travel up to 10%.
Seniority level Not Applicable
Employment type Full-time
Job function
Quality Assurance
Medical Equipment Manufacturing
Additional Notes Referrals increase your chances of interviewing at Brightpath Associates LLC by 2x.
Get notified about new Quality Engineer jobs in
Hayward, CA .
#J-18808-Ljbffr