Sr. Quality Engineer

Omnicell Specialty Pharmacy Services is seeking a Sr. Quality Engineer to join their Product Quality team. This role is responsible for ensuring that products meet design, development, and post-market requirements while leading quality initiatives and managing regulatory compliance.

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