Lead Quality Engineer
Company: Russell Solutions Group
Location: San Carlos
Posted on: February 14, 2026
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Job Description:
Job Description Job Description Position Overview We are seeking
a talented and motivated Principal Quality Engineer (or QA Manager)
to join our team full-time at our Bay Area facility. This is an
on-site position offering hands-on experience with cutting-edge
medical device technology. The Principal QE will be a key
contributor responsible for providing practical quality engineering
support for design and development, production, and general QMS
activities. The ideal candidate provides critical hands-on input
and leadership across various quality functions including design
controls, risk management, inspections, sterilization and testing.
The ideal candidate thrives in dynamic startup environments, brings
strong organizational and documentation skills combined with a
collaborative mindset, and is excited by the opportunity to make
meaningful contributions to a product that will directly impact
patient lives. This position offers the chance to shape the future
of our technology and organization for the right individual. Roles
and Responsibilities • Provides Design Quality Assurance support
throughout design, development, and production to ensure compliance
to internal and external requirements and standards (ISO 13485, ISO
14708, IEC 60601 etc). • Serves as the quality expert for and is
responsible for making key quality decisions including ownership of
design control and document control systems. • Supports risk
management activities based on ISO 14971 including risk management
planning, hazard analysis and FMEAs (Failure Mode Effects Analysis)
to evaluate and ensure product safety and functionality during
development and production • Manages supplier quality including
performing supplier qualifications. Also as needed, along with
technical team, works with key suppliers to ensure compliance to
product quality requirements and lead the resolution of product
quality issues • Provide key quality input towards planning and
execution of DV&V testing • Manages incoming parts inspections
to ensure components meet product specifications • Works with
sterilization vendor to outline device sterilization procedures and
manages sterilization lot release activities • Support company
goals and objectives, policies and procedures that are related to
the Quality Management System and Quality System Regulations
Required Qualifications • Bachelor's degree in Engineering or
related science field required • 8 years of design quality
assurance experience within an FDA regulated environment •
Demonstrable knowledge and working experience with Design Controls,
Risk Management (Hazard Analysis), Design and Process FMEA,
Statistical Analysis, Product Qualification, and Medical Device
Product Release • Experience in medical device manufacturing
environment with a strong working knowledge of QSR/cGMP, ISO 13485,
ISO 14971and IEC 60601 • Must be team oriented and have excellent
communication and interpersonal skills • Self-directed problem
solver with ability to balance independent work and collaborative
cross-functional initiatives • Strong documentation practices •
Prior role in an early-stage medical device company or startup
environment Preferred Qualifications • Experience with active
implantable medical devices (AIMDs) • Knowledge of ISO 14708
requirements and tests for active implantable devices • Experience
in the cardiovascular devices space
Keywords: Russell Solutions Group, Vacaville , Lead Quality Engineer, Science, Research & Development , San Carlos, California
