Sr. Quality Engineer

Omnicell is a company dedicated to transforming pharmacy care through innovative technology. The Sr. Quality Engineer is responsible for ensuring product compliance with design and regulatory standards while leading change control processes and quality improvement initiatives.

Responsibilities:

• Lead the execution of defect management and engineering escalation processes, ensuring timely identification, resolution, and reporting of product issues
• Drive the review and approval of design and service verification and validation protocols, with a focus on product changes and lifecycle processes
• Manage cross-functional teams in product change control processes and ensure comprehensive documentation of product modifications
• Take ownership of maintaining and updating the Device Master Record (DMR) for assigned product lines during post-market changes
• Ensure alignment of design outputs with inputs, proactively addressing discrepancies and ensuring compliance with internal protocols
• Act as the lead liaison between engineering, product management, and quality teams to integrate quality considerations early in the product design phase
• 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
• Conduct internal audits and manage corrective and preventive actions (CAPA) to ensure continued compliance and improvement

Requirements:

• Bachelor's degree in engineering
• Experience working in a regulated environment (i.e. ISO 9001, ISO 13485 or FDA regulated)
• Hands-on experience within product development
• 3+ years professional experience within quality space
• 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., SPC, Six Sigma)
• Experience in leading cross-functional teams and managing product changes from initiation through post-market stages
• Strong project management skills and the ability to manage multiple priorities effectively
• Excellent problem-solving, communication, and leadership abilities
• Experience in process development
• Experience with 14971 regulations
• Experience working with complex electro-mechanical systems