Quality Engineering Senior

Lead the execution of defect management and engineering escalation processes, ensuring timely identification, resolution, and reporting of product issues.
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.
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.
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., Understanding of software development lifecycle (SDLC) and experience in defect tracking platforms like Jira
• Strong project management skills and the ability to manage multiple priorities effectively.
• Bachelor's degree in Engineering or Science discipline
• 5+ years in Engineering, Quality or related technical professional experience
• Experience working in a regulated environment (i.e. Experience working with complex electro-mechanical systems

Experience working with Cloud software and AI/ML
Office Environment
May 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. 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.
As Passionate Transformers , we find a better way to innovate relentlessly.
Our Entrepreneurial spirit makes the most of EVERY opportunity for innovation.
We are deeply committed to Environmental, Social, and Governance (ESG) initiatives. 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. 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 offer support and reasonable adjustments for individuals with disabilities during our hiring process. 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.