**Quality Engineer III** Full-time, salary position on site in Milpitas, CA reporting to the Manager of Production Quality. The Quality Engineer III will be responsible for Production Quality activities for Omnicell’s Points of Care product line, including preparing and maintaining necessary documentation, monitoring production quality performance to identify opportunities for improvements, acting as a liaison between manufacturing, quality inspectors, and suppliers, and promoting quality awareness. **Core Responsibilities:** + Ensure compliance to internal QMS documentation and ISO 13485 and ISO 9001. + Assist in the establishment of quality acceptance criteria and activities including but not limited to first article, incoming, in-process, and final inspection. + Lead Material Review Board and coordinate the disposition of non-conforming materials. + Lead root cause analysis for non-conformances through brainstorming, use of fishbone diagrams, 8D methodologies, CAPA, and design of experiments, etc. + Work with manufacturing to document, edit, and communicate changes to items and assemblies within change control process. + Assist with the on-site aspects of the change control process to ensure seamless transitions. + Collaborate with design quality and engineering to determine critical part features that require monitoring. + Provide input into Process Validation activities. + Present operational and quality metrics related to process audits, MRB, and final inspection. + Maintain the Quality Management System. **Additional Responsibilities:** + Work with suppliers to establish and maintain controlled manufacturing processes + Oversee/Coordinate internal rework activities. + Support development of process FMEAs. + Support the Quality Department objectives and goals by managing or participating in Quality projects. + Lead and participate in CAPAs as required. + Additional work as assigned. **Required Knowledge and Skills:** + ISO 13485 and/or FDA (CFR 820) Medical Device knowledge. + Ability to effectively interface and communicate with multiple constituents, including senior management, customers, consultants, vendors, and employees of all levels. + Demonstrated problem solving skills. + Ability to work collaboratively with peers and team members. + Change agent who accepts and supports new ideas and processes. + Strongly demonstrated written and verbal communication and presentation skills. + Ability to consistently balance sense of urgency with diplomacy/empathy. + Strong time management skills and attention to detail. + Strongly demonstrated organizational and project management skills. + Demonstrated proficiency with common MS office programs (Word, Excel, PowerPoint, Project). + Team builder, self-starter, organized, and analytical. **Basic Qualifications:** + Bachelor of Science degree + Minimum five (5) years of experience in an engineering position + Experience with broad variety of measurement and quality data analysis techniques + ISO 13485 and/or FDA (CFR 820) regulated medical device experience **Preferred Qualifications:** + Bachelor of Science in Mechanical or Electrical Engineering + Experience in ISO 9001:2015 + Experience working with complex electro-mechanical systems + Experience with CMM programming and measurement techniques + Experience in Supplier Quality or Supplier Development **Work Conditions:** + Milpitas, CA - Onsite + Office Environment + May travel up to 10% 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 diversity and inclusion, 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. **About The Team** Omnicell is dedicated to fostering a diverse and 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 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. 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. Job Identification: 3760 Job Category: Quality Assurance Engineering Posting Date: 02/13/2025, 9:40 PM Job Schedule: Full time Locations: Milpitas, CA, United States Job Level: Experienced All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.