Quality Engineer III

About the position

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.

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.
• 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.

Requirements

• 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.

Nice-to-haves

• 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