Product Quality Engineer II — Regulated Med Devices

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

Benefits offered by this job

Medical benefits

Dental and vision plans

Retirement plans with matching

Paid time off

Job summary

Omnicell, a leader in clinical technology solutions, seeks 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 product change control, analyze data, and maintain regulatory compliance with strong communication and problem-solving skills across the organization.

Qualifications

• Bachelor's degree in Engineering or Science required.
• 2+ years in Engineering, Quality or related technical professional experience preferred.

Responsibilities

• Execute Defect Management and Engineering Escalation Processes.
• Review and approve design verification and validation protocols, plans, and records for product development and changes.
• Provide quality support for the Product Lifecycle Process.
• Lead and manage the product change control process with thorough documentation and detail.
• Create and distribute agendas, meeting minutes, and action items for cross-functional change control meetings.
• Facilitate meetings to ensure adherence to procedures and track progress with queries and metrics.
• Maintain the Device Master Record (DMR) during release and post-market changes.
• Ensure design outputs align with inputs and comply with protocols.

Skills

Defect tracking

Change control

Regulatory compliance

Quality metrics

Cross-functional collaboration

Communication

MS Office

Problem solving

Education

Bachelor's degree in Engineering or Science

Job description

Omnicell, a leader in clinical technology solutions, seeks 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 product change control, analyze data, and maintain regulatory compliance with strong communication and problem-solving skills across the organization.