Senior Quality Engineer, Medical Devices & QMS Lead

Abram Scientific; Menlo Park (CA); On-site; USD 150,000 - 210,000; Full time

Job summary

Abram Scientific, based in Menlo Park, CA, seeks a Lead Quality Engineer to develop and maintain our QMS while supporting the design, verification, validation, transfer, and manufacture of our medical device platform and disposables.

The role is hands-on, full-time, in-person, and requires cross-functional collaboration with engineering, manufacturing, operations, and regulatory teams to ensure compliance with FDA QSR (21 CFR Part 820), ISO 13485, and related standards.

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• 7+ years of Quality Engineering experience in the medical device industry working on FDA-regulated products.
• Thorough understanding of FDA Design Controls (21 CFR Part 820), ISO 13485, and DHF documentation.
• Experience with risk management methodologies (ISO 14971), failure analysis, and root cause investigation.
• Strong technical writing skills.
• Startup experience and cross-functional collaboration across engineering, manufacturing, operations, and regulatory.

Responsibilities

• Support Design Quality activities throughout product development and design control.
• Maintain and improve the Quality Management System (QMS) and ensure compliance with FDA and ISO standards.
• Develop inspection plans, PPAPs, and process validation activities.
• Lead CAPA investigations and ensure effectiveness verification.
• Coordinate supplier quality and external audits.
• Review verification and validation protocols and reports; ensure traceability across requirements, specifications, and risks.

Skills

Quality Engineering

Regulatory knowledge

Root cause analysis

Cross-functional collaboration

Technical writing

Startup experience

Education

Bachelor's degree in Engineering

Bachelor's degree in related discipline

Tools

Orcanos

Greenlight Guru

MasterControl

Arena

eQMS

Job description

Abram Scientific, based in Menlo Park, CA, seeks a Lead Quality Engineer to develop and maintain our QMS while supporting the design, verification, validation, transfer, and manufacture of our medical device platform and disposables.

The role is hands-on, full-time, in-person, and requires cross-functional collaboration with engineering, manufacturing, operations, and regulatory teams to ensure compliance with FDA QSR (21 CFR Part 820), ISO 13485, and related standards.