Product Quality Engineer II – Change & Compliance

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

Job summary

Omnicell is seeking a Product Quality Engineer II to partner with product management, engineering, and customer-facing teams to ensure our products meet design, development, and post-market requirements. The role emphasizes change control, data analysis, and regulatory compliance.

You will lead defect management, review validation protocols, maintain the Device Master Record, triage safety concerns, and drive continuous improvement through QMS processes.

Qualifications

• Bachelor's degree in Engineering or Science discipline.
• 2+ years in Engineering, Quality or related technical experience.
• Experience in regulated environments (ISO 9001, ISO 13485 or FDA).

Responsibilities

• Execute Defect Management and Engineering Escalation Processes.
• Review and approve design and service verification and validation protocols.
• Lead and manage the product change control process.
• Maintain the Device Master Record (DMR) throughout product release and post-market changes.
• Coordinate cross-functional change control meetings.

Skills

Interpersonal skills

Project management

Time management

Deadline-driven

Analytical

Decision making

MS Office

Jira

Education

Bachelor's degree in Engineering or Science

Tools

Jira

Job description

Omnicell is seeking a Product Quality Engineer II to partner with product management, engineering, and customer-facing teams to ensure our products meet design, development, and post-market requirements. The role emphasizes change control, data analysis, and regulatory compliance.

You will lead defect management, review validation protocols, maintain the Device Master Record, triage safety concerns, and drive continuous improvement through QMS processes.