📍 Location: Auburn, CA 🏢 Work Arrangement: On-Site

The Senior Quality Engineer leads cross-functional quality projects and initiatives to improve product quality, operational efficiency, compliance, and customer satisfaction. This role evaluates quality performance metrics, develops and improves quality processes, supports audits, and drives continuous improvement through data analysis and collaboration with business and technical teams.

Applying strong subject matter and industry expertise, the Senior Quality Engineer works independently with leadership alignment — serving as a trusted advisor on quality methodologies, best practices, and regulatory standards while mentoring and developing less experienced team members.

• Lead cross-functional quality improvement projects — developing, maintaining, and improving quality management system processes, procedures, and standards in partnership with appropriate stakeholders and leadership to support business objectives and customer requirements.
• Analyze quality trends, customer feedback, audit findings, and process performance metrics — identifying gaps, potential future issues, and improvement opportunities while facilitating root cause investigations and corrective and preventive action (CAPA) activities to reduce recurrence.
• Partner with engineering, operations, product management, and other stakeholders to incorporate quality requirements throughout the product lifecycle — assessing process controls and quality risks and recommending and executing solutions that improve efficiency, compliance, and product reliability.
• Support internal, customer, and regulatory audits — including preparation, documentation review, response coordination, and corrective action follow-up — while creating and maintaining quality dashboards, reports, and performance metrics to communicate results and track improvement efforts.
• Lead continuous improvement initiatives using Lean, Six Sigma, statistical analysis, and other quality tools — providing guidance and consultation on quality methodologies, best practices, industry standards, and regulatory requirements.
• Mentor, coach, train, and provide feedback to team members — influencing and assisting in the creation of team quality processes and standards in partnership with leadership, and contributing to the overall growth and quality excellence of the organization.

• Bachelor's degree in Engineering, Quality, Manufacturing, Industrial Engineering, Life Sciences, Computer Science, or a related field — or an equivalent combination of education and experience — with typically 5+ years of experience in quality engineering, quality assurance, process improvement, or a related discipline.
• Demonstrated experience leading quality improvement initiatives and cross-functional projects — including root cause analysis, corrective and preventive action (CAPA) implementation, and audit support for regulatory or industry compliance requirements.
• Strong understanding of quality management systems and continuous improvement methodologies — with knowledge of quality tools such as FMEA, CAPA, SPC, control plans, Pareto analysis, and root cause methodologies.
• Strong analytical, problem-solving, and decision-making skills — with the ability to analyze data, translate findings into actionable recommendations, and plan and complete assignments independently while maintaining leadership alignment.
• Strong written and verbal communication skills — with strong organizational, project management, and time management abilities, demonstrated mentoring and coaching capabilities, and up to 10% travel as required.

• ASQ Certified Quality Engineer, Six Sigma Green Belt or Black Belt, or equivalent certification — demonstrating a commitment to quality excellence and continuous professional development.
• Experience with ISO 9001, ISO 13485, FDA, SOX, or other applicable regulatory standards — with a track record of successfully supporting audits and navigating regulatory and industry compliance requirements.
• Experience using quality analytics, reporting tools, and statistical software — to support data-driven decision-making and drive measurable continuous improvement outcomes.
• Strong subject matter, product, or industry expertise — with the ability to provide guidance and consultation on quality methodologies, best practices, and industry standards across cross-functional teams.
• Experience influencing and assisting in the creation of team quality processes and standards — partnering with leadership to drive quality culture and operational excellence across the organization.

The base salary compensation range for this role is $125,450 - 134,639 per year. Actual compensation will be determined based on experience, qualifications, and other job-related factors in accordance with applicable laws.