Senior Supplier Quality Engineer - Medical Devices (Equity)

Zenflow; South San Francisco (CA); On-site; USD 120,000 - 135,000; Full time

Benefits offered by this job

Equity

Comprehensive benefits

Job summary

Zenflow is seeking a Senior Quality Engineer to build and manage the supplier quality program as its first product launches. You will lead supplier qualification, audits, and QC processes, drive CAPA, and ensure regulatory compliance across FDA and ISO standards.

The role requires a strong ownership mindset, cross-functional collaboration, and travel to supplier sites. You will work with R&D, Manufacturing, and Regulatory to qualify suppliers, maintain ASL, and implement robust IQC and QMS

Qualifications

• 5+ years quality engineering experience in the medical device industry.
• Experience leading supplier quality programs and SCARs.
• Experience conducting supplier audits (ISO 13485 / FDA QSR) and CAPA.
• Proficiency with quality tools (FMEA, SPC, 8D, root cause analysis).
• Familiarity with FDA 21 CFR Part 820 and ISO 13485; risk management standards.

Responsibilities

• Lead supplier qualification, SQPs, and audits.
• Manage Approved Supplier List (ASL) maintenance and QMS documentation.
• Drive CAPA and root cause analysis with suppliers; escalate issues as needed.
• Support supplier performance reviews and cross-functional collaboration.

Skills

Supplier quality

Quality systems

Cross-functional collaboration

Auditing

Quality problem solving

Education

Bachelor's degree in engineering

ASQ CQE/CQA preferred

Tools

eQMS platforms (Greenlight Guru, MasterControl, Veeva Vault)

Job description

Zenflow is seeking a Senior Quality Engineer to build and manage the supplier quality program as its first product launches. You will lead supplier qualification, audits, and QC processes, drive CAPA, and ensure regulatory compliance across FDA and ISO standards.

The role requires a strong ownership mindset, cross-functional collaboration, and travel to supplier sites. You will work with R&D, Manufacturing, and Regulatory to qualify suppliers, maintain ASL, and implement robust IQC and QMS