Quality Engineer II

Product Quality Engineer, II

The 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 Processes
• Review 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 Process
• Lead 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 levels
• Ability to work collaboratively with peers and team members
• Strong organizational and project management skills
• Refined multi-tasking and time management skills
• Ability to work under tight deadlines
• Self-starter, organized, analytical and decisive
• Strong written and verbal communication and presentation skills 
• Ability to consistently balance sense of urgency with diplomacy/empathy
• Ability to make decisions and execute directives
• Demonstrated proficiency with common MS office programs (Word, Excel, PowerPoint, Project)
• Experience in defect tracking platforms like Jira

Basic Qualifications:

• Bachelor’s degree in Engineering or Science discipline
• 2+ years in Engineering, Quality or related technical professional experience

Preferred 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 
• QMSR
• Experience working with complex electro-mechanical systems
• Understanding 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/ML

Work Conditions:

• Office Environment
• May travel up to 25%