Quality Engineer II: Elevate Medical Device Quality

Omnicell, Inc.; Cranberry Township (Butler County); On-site; USD 75,000 - 95,000; Full time

Job summary

Omnicell, Inc. is seeking a Product Quality Engineer, II to partner with product management, engineering, and customer-facing teams. You will lead change control, assess verification/validation data, and ensure post-market compliance for medical device software and hardware.

The role emphasizes cross-functional collaboration, data-driven improvements, and adherence to ISO 9001/13485 and FDA QMS standards. Strong communication and problem-solving are essential.

Qualifications

• Bachelor’s degree in Engineering or Science discipline.
• 2+ years in Engineering, Quality or related technical professional experience.
• Experience in defect tracking platforms like Jira.

Responsibilities

• Change Control and Design: Execute defect management and engineering escalation processes.
• Review and approve verification/validation protocols, plans, and records.
• Lead product change control meetings with cross-functional teams.
• Maintain the Device Master Record (DMR) through releases and changes.
• Triage quality issues reported during installation and use.
• Drive MDR processes and risk management activities.

Skills

Quality engineering

Regulatory compliance

Analytical thinking

Communication

Problem solving

Education

Bachelor’s degree in Engineering or Science

Tools

Jira

MS Office

Job description

Omnicell, Inc. is seeking a Product Quality Engineer, II to partner with product management, engineering, and customer-facing teams. You will lead change control, assess verification/validation data, and ensure post-market compliance for medical device software and hardware.

The role emphasizes cross-functional collaboration, data-driven improvements, and adherence to ISO 9001/13485 and FDA QMS standards. Strong communication and problem-solving are essential.