Senior Quality Engineer

Overview Senior Quality Engineer 📍 Location: Auburn, CA 🏢 Work Arrangement: On-Site About the Role The Senior Quality Engineer leads cross-functional quality projects and initiatives to improve product quality, operational efficiency, design and development, change management, 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 quality standards while mentoring and developing less experienced team members. Your Role Responsibilities? Here's What You'll Do. Maintain and improve the Quality Management System (QMS) in alignment with ISO 13485, FDA QSMR, and internal procedures — ensuring all processes adhere to internal quality system procedures and managing quality system elements such as incoming inspection, CAPA, NCRs, complaint handling, change control, and document control eQMS. Assist and manage design reviews — ensuring compliance with Design and Development requirements and applying working knowledge of ISO 14971 Risk Management, IEC 60601-1 Electrical Safety, IEC 62304 Software, IEC 62366-1 Usability, and IEC 81001-5-1 Cybersecurity standards — while supporting verification and validation (V&V) activities, including test method validation. Support production teams in resolving quality issues — identifying root causes and implementing corrective and preventive actions — while assisting with the evaluation of suppliers, maintaining supplier performance metrics, and managing supplier corrective actions and continuous improvement initiatives. Support internal and external audits and regulatory inspections — analyzing quality data to identify trends, process capability, and improvement opportunities — and assisting with quality objective reporting for management reviews, manufacturing process KPIs, audit findings, and CAPA status. 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. 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. Role Essentials 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 per ISO 13485:2016 and continuous improvement methodologies — with working knowledge of quality elements such as Design and Development, Design Verification and Validation, FMEA, Risk Management, CAPA, Change Control, Complaint System, and Manufacturing Process Controls. 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. What We'd Like to See 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 QMSR, SOX, and other applicable regulatory standards — with a track record of successfully supporting audits and navigating regulatory quality and industry compliance requirements. Experience using quality analytics, reporting tools, and statistical software — with working knowledge of Word and Excel to support data-driven decision-making and drive measurable continuous improvement outcomes. Strong subject matter expertise in quality and compliance — 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. Please Note: The candidate must adhere to and follow the Hyland Software Inc. Quality Management System (QMS) . Pay Transparency 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. About Hyland Hyland is the pioneer of the Content Innovation Cloud™, delivering ubiquitous enterprise intelligence to organizations with solutions that unlock actionable insights and drive automation. Trusted by thousands of organizations worldwide, including many of the Fortune 100, Hyland's solutions create the foundation for a connected, agentic enterprise, where teams harness the power of AI to redefine how they operate and engage with those t