Senior Quality Engineer

Hyland; Auburn (CA); On-site; USD 125,000 - 135,000; Full time

Job summary

Hyland is seeking a Senior Quality Engineer in Auburn, CA, on-site, to lead cross-functional quality initiatives and improve product quality and regulatory compliance. The role requires mentoring teammates, driving CAPA, and partnering with engineering and product teams to embed quality across the lifecycle.

You will analyze quality performance, develop processes, and support audits, leveraging Lean, Six Sigma, and data analytics to deliver measurable improvements and maintain the Hyland QMS.

Qualifications

• Bachelor's degree or equivalent in Engineering/Quality/Manufacturing or related field.
• Experience in quality engineering, quality assurance, or process improvement is required.
• Experience leading quality initiatives and CAPA for regulatory/compliance requirements.

Responsibilities

• Lead cross-functional quality improvement projects and maintain quality management system processes and standards.
• Analyze quality trends, audit findings and metrics; identify gaps and drive CAPA actions.
• Partner with engineering, operations, product management to embed quality throughout the product lifecycle.
• Support internal, customer, and regulatory audits; prepare documentation and coordinate corrective actions.
• Lead continuous improvement using Lean, Six Sigma, and statistical tools; mentor team members on quality practices.

Skills

Cross-functional leadership

Data analysis

Quality improvement

Problem solving

Communication skills

Mentoring

Education

Bachelor's degree in Engineering or related field

Tools

MS Word

Excel

Job description

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, 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.

Your Role Responsibilities? Here's What You'll Do.

• 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.

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 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 — with working knowledge of quality elements such as Design and Development, Design Verification and Validation, 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 or equivalent certification — demonstrating a commitment to quality excellence and continuous professional development.
• Experience with ISO 13485, FDA QMSR, and other applicable regulatory standards — with a track record of successfully supporting audits and navigating quality and industry compliance requirements.
• Experience using quality analytics, reporting tools, and a working knowledge of Word and Excel software — 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 they serve. For additional information on Hyland's platform and services, please visit Hyland.com.

Hyland. All rights reserved.

About Hyland Life

#HylandLife

Since 1991, it has been Hyland's mission to help our employees, customers and partners exceed their potential with our industry-leading content services platform. Our employees exude a contagious energy and are passionate about what they do – whether it's helping customers succeed, raising up their fellow Hylanders, or engaging in the communities where they live and work.

The #HylandLife hashtag encompasses our employee-centric culture. Our employees live our culture day in and day out by bringing their best self to work. Hyland supports them to do just that through career development resources, wellbeing programs and innovation practices. We thrive on diverse viewpoints and new ideas and believe that a positive, inclusive workplace is imperative to sustainable success.

As we've grown to a company of nearly 4,000 strong, we have the opportunity to make a significant impact on our communities. We strongly support employee initiatives and align our giving campaigns and programs to organizations that are important to them.

Equal Opportunity Statement

Hyland is an equal opportunity employer. We value diversity and are committed to providing an inclusive workplace for all employees and applicants. Employment decisions are made without regard to any characteristic protected by applicable laws and regulations. Information collected during the hiring process is used solely to assess qualifications, verify identity, and comply with legal requirements.