Quality Systems Engineer

About the role

You own the conversion of product concepts into compliant execution by applying documented procedures and technical judgment. You serve as the clear communication bridge between technical teams and quality requirements to maintain consistency across regulated programs. You systematically analyze processes to ensure adherence to internal standards and regulatory expectations for every project. You guide cross-functional partners in implementing design controls, product validation, and process validation with rigorous traceability. You utilize risk methods such as failure mode and effects analysis to proactively identify and address product or system weaknesses. You produce documentation that is precise, accurate, and structured to support quality processes and informed decisions for reviewers and regulators. You exercise professional judgment and high integrity to uphold consistent compliance and rigorous standards across all quality initiatives.

Key facts

What you'll do

Define clear product and process requirements that specify how systems must perform to satisfy internal and regulatory safety and performance standards.

Create and maintain documentation that describes design controls, investigational studies, and clinical trials to ensure regulated activities align with evidence and explicit requirements.

Apply design validation, process validation, and risk-based methods to routine activities, ensuring traceability and compliance for every deliverable.

Leverage guidance from Good Clinical Practice, human factors, FDA QMSR, ISO 13485, and ISO 14971 to determine necessary actions and decisions for quality processes.

Perform failure mode and effects analysis within risk management activities to evaluate potential issues and prioritize corrective actions for product or system weaknesses.

Author documentation that is produced clearly and accurately to support quality processes, regulatory review, and informed decision-making by stakeholders.

Use professional judgement to interpret regulations and standards, ensuring high integrity and consistent compliance across all quality initiatives and project lifecycles.

Collaborate with engineering, clinical, and operations teams to align software development practices with quality system requirements and regulatory expectations.

Requirements

The posting states a bachelor's degree requirement; you must possess at least 2 years of industry experience in quality systems for regulated environments.

Your background must include demonstrated understanding of design controls, product validation, process validation, and risk methods applied in routine activities.

You must be familiar with guidance from Good Clinical Practice, human factors, FDA QMSR, ISO 13485, and ISO 14971 as they inform quality processes and decisions.

You must have experience using failure mode and effects analysis to evaluate potential issues within risk management frameworks.

You must produce documentation that is clear and accurate to effectively support quality processes and satisfy reviewers and regulators.

You must exercise professional judgement and maintain high integrity to uphold rigorous standards and consistent compliance across quality initiatives.

You must understand how to apply quality system principles to software development lifecycle activities in regulated settings.

You must be able to work in the United States and meet onsite presence expectations in San Francisco on specified days.

Practical notes

Working in the United States requires authorization to work in this country. Onsite presence in San Francisco on specified days is expected. Limited travel within the region may occur for collaboration or regulatory activities.

Typical interview steps

Hiring for engineering roles usually starts with a recruiter screen, followed by one or two technical rounds. Candidates often solve a coding problem, discuss past projects, and answer system design questions. Some loops include a take-home task. Final rounds typically cover team fit and give candidates a chance to ask questions. Interviewers look for how you break down an unfamiliar problem, not just whether you reach the answer. Practicing a few problems aloud and reviewing your own past projects are the best preparation.

Good to know

Writing shapes how teams describe problems and solutions in regulated settings, turning complex requirements into clear and actionable documentation. Clarity, standards, and methods guide decisions in quality focused work, where traceability and risk analysis are central. Risk tools, documentation practices, and validation approaches structure everyday activities to ensure reliability and compliance. Engineers build software in small teams, review peers, and deliver in batches to iterate quickly while maintaining quality. Testing, debugging, and performance improvements complement new feature development to ensure stable releases. General analytical methods help professionals explain technical choices in plain language, making technical concepts accessible to diverse stakeholders.

Career growth

Engineering careers usually progress from individual contributor to senior, staff, and principal levels. Some engineers move into management and lead teams of five to twenty people. Others stay on the technical track. Growth follows demonstrated impact, not tenure alone. A typical engineering ladder has clear levels with defined expectations for scope, quality, and mentorship. Moving up usually requires owning outcomes end to end rather than completing assigned tickets.