Staff Quality Engineer

Job ID

4663

Date posted

10/17/2025

Department

ENG

Work Location Type

Hybrid

Staff Product Quality Engineer

Omnicell is seeking a Staff Quality Engineer that will report into a Manager or Sr. Manager of Product Quality.  The Product Quality team partners with product management, engineering, and customer-facing organizations to consistently fulfill the needs of our customers by providing end-to-end quality support for our products and services through the execution of our QMS processes.  This specific role will be supporting the new product development of software including requirement development, verification and validation strategies and testing, and compliance with regulatory standards.

Responsibilities:

• Serve as the primary quality representative in the development of On-premise, Edge, Cloud and SaaS software collaborating with engineering, product management, and operations to ensure quality is embedded into the product.
• Establish touchpoints and the level of sprint and backlog engagement required for efficient quality support of software development.
• Liaise with Regulatory and other Quality departments throughout the product development process for necessary inputs into development.
• Work with safety risk management and the supporting team to create a risk file during the development of the product and ensure the incorporation of appropriate design mitigations. 
• Review and approve verification and validation protocols, and final design outputs, ensuring consistency with quality, regulatory and safety standards.
• Champion continuous improvement initiatives, identifying opportunities to enhance product quality and optimize internal processes.
• Develop and implement advanced quality metrics, presenting findings to senior leadership and drive actions to meet key performance indicators (KPIs).
• Support post-market surveillance activities including software patch validation, complaint trending, and field issue resolution.
• Support external audits and regulatory inspections, ensuring full compliance with ISO and other relevant regulatory bodies.
• Knowledge of QMS processes and regulatory standards (ISO 9001 or 13485).
• Demonstrated ability to lead large-scale quality projects, including product development and risk mitigation.
• Strong leadership and decision-making skills, with the ability to influence cross-functional teams and senior leadership.
• Experience working with software engineers throughout sprint and release processes.
• Exceptional technical communication skills.

Required Knowledge and Skills:

Basic Qualifications:

• Bachelor’s degree in Engineering or Science discipline
• 3-6 years professional experience
• Cloud/SaaS experience 
• Experience in product development

Preferred Qualifications:

• 7+ years professional experience
• Experience in process development  
• Experience working with medical devices (i.e. ISO 13485 or FDA regulated)
• Expertise in machine learning and generative AI

Work Conditions:

• Office Environment
• May travel up to 10%

EEO, Privacy, and Adaptability

Omnicell welcomes applications from all individuals, valuing a wide range of perspectives and backgrounds. As an equal opportunity employer, we do not discriminate based on race, gender, religion, sexual orientation, gender identity, national origin, veteran status, or disability. We are committed to making our recruitment process accessible to everyone. We offer support and reasonable adjustments for individuals with disabilities during our hiring process. If you need assistance, please contact us at Recruiting@omnicell.com.At Omnicell, respect for privacy and confidentiality is paramount. We adhere to strict policies to prevent discrimination or retaliation against those who engage in open conversations about compensation. However, employees privy to compensation information as part of their job role are expected to maintain confidentiality, except in specific circumstances outlined by law, such as during formal complaints, investigations, or as required by legal obligations. Learn more about our privacy practices: https://www.omnicell.com/privacy/Please note that Omnicell reserves the right to modify job roles and responsibilities as needed to meet our organization's evolving needs and drive our mission forward.

About Us

At Omnicell, innovation starts with people who are passionate about making healthcare safer and smarter. Since 1992, we’ve been transforming the future of pharmacy care through bold ideas and hands-on solutions that make a real impact on clinicians and patients’ lives.We build outcomes-driven technology—from robotics to intelligent software—that helps clinicians work more efficiently and ensures patients get the care they need. Every improvement, every breakthrough, every idea is rooted in our belief that better is always possible.But what sets us apart isn’t just the work we do, it’s how we do it. Our Culture of Care shapes everything, from how we show up for each other to how we solve tough problems together. You’ll find a team that has your back, leaders who listen, and a shared commitment to building something that matters.Here, careers are more than job titles, they are journeys of purpose and possibility. Whether you’re just getting started or ready to grow in new directions, we’ll meet you where you are, with support, flexibility, and opportunity that matches your ambition.If you’re driven by purpose and ready to shape what’s next in healthcare, there’s a place for you at Omnicell.