Product Quality Engineer II: Quality & Compliance

Omnicell; Pittsburgh (Allegheny 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 through the execution of our QMS processes.

The ideal candidate will lead product change control, review complaints, analyze data, and maintain regulatory compliance with ISO 9001/13485 standards, while driving risk management and continuous improvement across the product lifecycle.

Qualifications

• Bachelor’s degree in Engineering or Science.
• 1-2 years professional experience.
• Experience in product development/maintenance.
• Experience in a regulated environment (ISO 9001, ISO 13485 or FDA).
• Experience with complex electro-mechanical systems.
• Experience with software throughout the product lifecycle.

Responsibilities

• Execute Defect Management and Engineering Escalation Processes.
• Review and approve design and verification/validation protocols and records.
• Provide quality support for the Product Lifecycle Process.
• Lead and manage the product change control process with thorough documentation.
• Create agendas, meeting minutes and action items for cross‑functional meetings.
• Facilitate change control meetings and track progress via queries and metrics.
• Maintain the Device Master Record (DMR) through release and changes.
• Lead complaint review activities, risk assessments, and investigations.
• Triage quality issues and safety concerns during installation and use.
• Drive MDR processes and Field Action/Recalls; participate in Safety Risk Management Board meetings.
• Ensure ISO 9001/13485 compliance; drive improvements with quality metrics.
• Engage with teams to optimize QA records and product documentation control.

Skills

Communication skills

Project management

Time management

Multitasking

Decision making

MS Office proficiency

Analytical

Collaboration

Education

Bachelor’s degree in Engineering or Science

Tools

MS Office

Analytics platforms

Automation tools

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 through the execution of our QMS processes.

The ideal candidate will lead product change control, review complaints, analyze data, and maintain regulatory compliance with ISO 9001/13485 standards, while driving risk management and continuous improvement across the product lifecycle.