Quality Engineer II

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 skills Ability 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 maintenance Experience in process development Experience working in a regulated environment (i.e. ISO 9001, ISO 13485 or FDA QMSRExperience 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%
Since 1992, Omnicell has been committed to transforming pharmacy care through outcomes-centric innovation designed to optimize clinical and business outcomes across all settings of care. We strive to be the healthcare provider’s most trusted partner by our guiding promise of “Outcomes. Defined and Delivered.”   
Our comprehensive portfolio of robotics, smart devices, intelligent software, and expert services is helping healthcare facilities worldwide to improve business and clinical outcomes as they move closer to the industry vision of the Autonomous Pharmacy. 
Our guiding principles inform everything we do: 
As Passionate Transformers, we find a better way to innovate relentlessly. Being Mission Driven, we consistently deliver on our promises. Our Entrepreneurial spirit makes the most of EVERY opportunity for innovation. Understanding that Relationships Matter creates synergies that yield the greatest benefits for all.Intellectually Curious, eager to think deeper to learn and improve.In Doing the Right Thing, we lead by example in ALL we do. 
We are deeply committed to Environmental, Social, and Governance (ESG) initiatives. Our ESG efforts focus on creating an inclusive culture and a healthier world. This includes our Employee Impact Groups, which foster inclusion and belonging, as well as our learning and well-being programs that support personal and professional growth. We also prioritize sustainability in our operations, aiming to reduce our environmental footprint and promote responsible business practices. Join us in transforming the pharmacy care delivery model, making patient care safer and smarter for all.
Omnicell is dedicated to fostering an inclusive workplace. We welcome 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 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,employeesprivy 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. 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.Full timePosting Date: