Sr. Quality Engineer

Omnicell, Inc.; Cranberry Township (Butler County); On-site; USD 80,000 - 115,000; Full time

Benefits offered by this job

Medical, dental and vision plans

Retirement plans with matching

Paid time off

Wellness programs

Life insurance

Disability insurance

Job summary

Omnicell, Inc. is seeking a quality-focused engineer to lead post-market involvement, defect management, and design verification across product lines in a regulated healthcare environment.

You will drive CAPA, MDR processes, and cross-functional collaboration with engineering, product management, and regulatory teams. This role emphasizes maintaining ISO 9001/13485 compliance, robust risk management, and lifecycle product changes from initiation to post-market support.

Qualifications

• Bachelor’s degree in Engineering or Science is required.
• 5+ years in Engineering, Quality or related technical professional experience.
• Experience in product development and/or maintenance in a regulated environment (ISO 9001, ISO 13485 or FDA QMSR).
• Experience leading cross-functional teams and managing product changes from initiation through post-market stages.
• Strong problem-solving and leadership abilities.

Responsibilities

• Lead the execution of defect management and engineering escalation processes, ensuring timely identification, resolution, and reporting of product issues.
• Drive review and approval of design and service verification and validation protocols, with a focus on product changes and lifecycle processes.
• Manage cross-functional teams in product change control processes and ensure comprehensive documentation of product modifications.
• Maintain and update the Device Master Record (DMR) for assigned product lines during post-market changes.
• Ensure alignment of design outputs with inputs, addressing discrepancies and ensuring compliance with internal protocols.
• Act as the lead liaison between engineering, product management, and quality teams to integrate quality considerations in the design phase.
• Independently process and triage out-of-box quality issues, conducting root cause analyses and driving corrective actions.
• Lead post-production safety risk assessments and implement solutions to mitigate safety concerns.
• Drive the Medical Device Reporting (MDR) process, coordinating with regulatory bodies and managing field actions and recalls.
• Present safety and risk management updates during Safety Risk Management Board Meetings, with responsibility for product-specific risks.
• Lead quality improvement projects to optimize processes, reduce defects, and improve customer satisfaction.
• Ensure adherence to ISO 9001, ISO 13485, and other regulatory standards, acting as a subject matter expert for compliance.
• Implement and analyze quality metrics and generate reports to monitor performance and drive improvements.
• Conduct internal audits and manage CAPA to maintain compliance and drive continuous improvement.

Skills

QMS knowledge

Root cause analysis

Statistical analysis

Project management

Cross-functional collaboration

Leadership

Communication

Education

Bachelor’s degree in Engineering or Science

Tools

Jira

Job description

Responsibilities:Change Control and Design:Lead the execution of defect management and engineering escalation processes, ensuring timely identification, resolution, and reporting of product issues.Drive the review and approval of design and service verification and validation protocols, with a focus on product changes and lifecycle processes.Manage cross-functional teams in product change control processes and ensure comprehensive documentation of product modifications.Take ownership of maintaining and updating the Device Master Record (DMR) for assigned product lines during post-market changes.Ensure alignment of design outputs with inputs, proactively addressing discrepancies and ensuring compliance with internal protocols.Act as the lead liaison between engineering, product management, and quality teams to integrate quality considerations early in the product design phase.Field, Customer and Safety:Independently process and triage out-of-box quality issues, conducting root cause analyses and collaborating with teams to drive corrective actions.Lead post-production safety risk assessments and implement solutions to mitigate safety concerns.Drive the Medical Device Reporting (MDR) process, coordinating with regulatory bodies and managing field actions and recalls.Present safety and risk management updates during Safety Risk Management Board Meetings, with responsibility for product-specific risks.Compliance and Continuous Improvement:Lead quality improvement projects aimed at optimizing processes, reducing defects, and enhancing customer satisfaction.Ensure adherence to ISO 9001, ISO 13485, and other relevant regulatory standards, acting as a subject matter expert for compliance.Implement and analyze quality metrics, creating reports to monitor process performance and drive data-driven improvements.Conduct internal audits and manage corrective and preventive actions (CAPA) to ensure continued compliance and improvement. Required Knowledge and Skills:Advanced knowledge of QMS (Quality Management System) documentation and regulatory standards (ISO 9001, ISO 13485).Proficiency in quality investigation tools (e.g., Fishbone diagrams, 5 Whys) and statistical analysis (e.g., SPC, Six Sigma).Understanding of software development lifecycle (SDLC) and experience in defect tracking platforms like JiraExperience in leading cross-functional teams and managing product changes from initiation through post-market stages.Strong project management skills and the ability to manage multiple priorities effectively.Excellent problem-solving, communication, and leadership abilities.Basic Qualifications:Bachelor’s degree in Engineering or Science discipline5+ years in Engineering, Quality or related technical professional experienceExperience in product development and/or maintenanceExperience in process developmentExperience working in a regulated environment (i.e. ISO 9001, ISO 13485 or FDA QMSR)Preferred Qualifications:Experience working with complex electro-mechanical systemsExperience working with Cloud software and AI/MLWork Conditions:Office EnvironmentMay travel up to 25%Base Compensation: $80,000.00 to $115,000.00(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.)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.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.