Product Quality Engineer II — Regulated Medical Devices

Omnicell; Pittsburgh (Allegheny County); On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision plans

Retirement plan with matching

Paid time off

Job summary

Omnicell is seeking a Product Quality Engineer II to partner with product management, engineering, and customer-facing teams to ensure products meet design, development, and post-market requirements. You will lead change control, analyze data, and maintain compliance with ISO 9001/13485 and FDA requirements, driving quality improvements across the product lifecycle.

Strong communication and analytical skills are essential to manage risk and deliver safe, effective medical device software and

Qualifications

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

Responsibilities

• Execute Defect Management and Engineering Escalation Processes.
• Review and approve verification and validation protocols, plans, and records related to product development and product changes.
• Quality support for Omnicell's Product Lifecycle Process.
• Lead and manage the product change control process, ensuring all changes are documented.
• Create and distribute agendas, meeting minutes, and action items for cross functional change control meetings.
• Facilitate meetings through the change control process and track progress with queries and metrics.

Skills

Communication skills

Project management

Analytical thinking

Time management

Education

Bachelor's degree in Engineering or Science discipline

Tools

Jira

Microsoft Office

Job description

Omnicell is seeking a Product Quality Engineer II to partner with product management, engineering, and customer-facing teams to ensure products meet design, development, and post-market requirements. You will lead change control, analyze data, and maintain compliance with ISO 9001/13485 and FDA requirements, driving quality improvements across the product lifecycle.

Strong communication and analytical skills are essential to manage risk and deliver safe, effective medical device software and