Quality Engineer II

Omnicell, Inc.; Cranberry Township (Butler County); On-site; USD 75,000 - 95,000; Full time

Job summary

Omnicell, Inc. is seeking a Product Quality Engineer, II to partner with product management, engineering, and customer-facing teams. You will lead change control, assess verification/validation data, and ensure post-market compliance for medical device software and hardware.

The role emphasizes cross-functional collaboration, data-driven improvements, and adherence to ISO 9001/13485 and FDA QMS standards. Strong communication and problem-solving are essential.

Qualifications

• Bachelor’s degree in Engineering or Science discipline.
• 2+ years in Engineering, Quality or related technical professional experience.
• Experience in defect tracking platforms like Jira.

Responsibilities

• Change Control and Design: Execute defect management and engineering escalation processes.
• Review and approve verification/validation protocols, plans, and records.
• Lead product change control meetings with cross-functional teams.
• Maintain the Device Master Record (DMR) through releases and changes.
• Triage quality issues reported during installation and use.
• Drive MDR processes and risk management activities.

Skills

Quality engineering

Regulatory compliance

Analytical thinking

Communication

Problem solving

Education

Bachelor’s degree in Engineering or Science

Tools

Jira

MS Office

Job description

Product Quality Engineer, IIThe 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.The Product Quality Engineer at Omnicell is responsible for ensuring that our products meet all design, development, and post-market requirements. This role involves leading product change control and product development processes, analyzing data, and maintaining compliance with regulatory standards. The ideal candidate will be versatile, analytical, and detail-oriented, with strong communication and problem-solving skills.Responsibilities:Change Control and Design:Execute Defect Management and Engineering Escalation ProcessesReview and approve design and service verification and validation protocols, plans, and records related to product development and product changes.Quality support for Omnicell’s Product Lifecycle ProcessLead and manage the product change control process, ensuring all requested changes are thoroughly documented and detailed.Create and distribute agendas, meeting minutes, and action items for cross-functional change control meetings.Facilitate meetings throughout the change control process to ensure adherence to procedures and track progress through queries and metrics.Maintain the Device Master Record (DMR) throughout product release and post-market changes.Ensure that design outputs align with design inputs and are compliant with established protocols.Field, Customer and Safety:Review, log, and triage out-of-box quality issues and potential safety concerns reported during product installation and use.Collaborate with cross-functional teams to address quality and safety issues promptly and effectively by investigating potential safety concerns and performing post-production safety risk assessments as applicable.Participate in Safety Risk Management Board Meetings and drive product-specific risk management tasks and updates.Drive the process for Medical Device Reporting (MDR) to regulatory agencies and manage the Field Action Process and Recalls.Compliance and Continuous Improvement:Ensure compliance with internal Quality Management System (QMS) documentation and regulatory standards such as ISO 9001 and ISO 13485.Utilize quality investigation and problem-solving tools to analyze complaint trends and drive improvements.Produce and review metrics related to quality processes, driving actions based on established thresholds and benchmarks.Support Quality Department objectives by managing or participating in quality improvement projects.Encourage the use of the Quality Management System and create processes to enhance customer-facing activities.Engage with various teams to optimize quality system records and ensure proper product document control.Required Knowledge and Skills:Ability to effectively interface and communicate with multiple constituents, including senior management and employees of all levelsAbility to work collaboratively with peers and team membersStrong organizational and project management skillsRefined multi-tasking and time management skillsAbility to work under tight deadlinesSelf-starter, organized, analytical and decisiveStrong written and verbal communication and presentation skillsAbility to consistently balance sense of urgency with diplomacy/empathyAbility to make decisions and execute directivesDemonstrated proficiency with common MS office programs (Word, Excel, PowerPoint, Project)Experience in defect tracking platforms like JiraBasic Qualifications:Bachelor’s degree in Engineering or Science discipline2+ years in Engineering, Quality or related technical professional experiencePreferred Qualifications:Experience in product development and/or maintenanceExperience in process developmentExperience working in a regulated environment (i.e. ISO 9001, ISO 13485 or FDAQMSRExperience working with complex electro-mechanical systemsUnderstanding of software development lifecycle (SDLC) processes, 21 CFR Part 11 (Electronic Records/Signatures), and IEC 62304 (Medical Device Software Lifecycle)Experience working with Cloud software and AI/MLWork Conditions:Office EnvironmentMay travel up to 25%Base Compensation: $75,000.00 to $95,000.00(Actual compensation is subject to variation due to such factors as location, education, experience, and skillset. We offer a comprehensive benefits package, including medical, dental and vision plans covering eligible US employees and dependents, voluntary wellness and employee assistance programs, life insurance, disability, retirement plans with matching, and paid time off.)EEO, Privacy, and AdaptabilityOmnicell 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 [e-mail] 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 UsAt 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.