Senior Supplier Quality Engineer – Med Device & Startups

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

Job summary

Zenflow, Inc. in South San Francisco, CA, seeks a Senior Quality Engineer to build and own the supplier quality program as the company scales its first product.

You will lead supplier qualification, audits, and CAPA, working closely with R&D, Manufacturing Operations, and Regulatory to ensure quality across the supply chain. You will drive supplier performance, implement IQC criteria, and support FDA/ISO compliance while contributing to broader quality initiatives.

Qualifications

• Bachelor's degree in Engineering, Materials Science, Biomedical Engineering, or equivalent.
• ASQ CQE, CQA preferred.
• 5+ years quality engineering in the medical device industry.
• Experience leading supplier audits and SCARs.
• Knowledge of FDA 21 CFR Part 820 and ISO 13485.
• Strong analytical and problem-solving skills.

Responsibilities

• Lead supplier qualification and onboarding plans and audits.
• Develop IQC processes and inspection criteria.
• Manage supplier performance scorecards and CAPA/SCAR processes.
• Support internal and external audits and regulatory compliance.
• Collaborate with R&D, Manufacturing, and Regulatory.
• Drive continuous improvement of supplier quality programs.

Skills

Supplier quality management

Quality systems

Audits

CAPA

FMEA

SPC

eQMS

Cross-functional collaboration

Problem solving

Ownership

Education

Bachelor's degree in Engineering, Materials Science, Biomedical Engineering

Tools

Greenlight Guru

MasterControl

Veeva Vault

Job description

Zenflow, Inc. in South San Francisco, CA, seeks a Senior Quality Engineer to build and own the supplier quality program as the company scales its first product.

You will lead supplier qualification, audits, and CAPA, working closely with R&D, Manufacturing Operations, and Regulatory to ensure quality across the supply chain. You will drive supplier performance, implement IQC criteria, and support FDA/ISO compliance while contributing to broader quality initiatives.