Product Quality Engineer II: Lifecycle & Compliance

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

Benefits offered by this job

Medical, dental and vision plans

Retirement plans with matching

Paid time off

Job summary

Omnicell seeks a Product Quality Engineer II to join the Quality team and ensure product compliance across design, development, and post-market phases. You will drive change control, review complaints, analyze data, and coordinate with cross-functional teams to meet regulatory requirements.

The role requires strong analytical skills, effective communication, and a proactive approach to risk management and process improvements within a fast-paced setting.

Qualifications

• Bachelor's degree in Engineering or Science required.
• Experience in regulated product environments preferred.
• Strong communication and problem-solving skills.

Responsibilities

• Lead product change control and document changes.
• Review and approve verification/validation protocols and records.
• Provide QA support across product lifecycle processes.
• Drive cross-functional change control meetings and actions.
• Manage Device Master Record during releases and updates.
• Lead complaint reviews, trend monitoring, and risk assessments.
• Support MDR processes and post-market actions.
• Ensure compliance with ISO 9001 / ISO 13485 and internal QMS.
• Improve quality processes using data-driven insights.

Skills

Cross-functional communication

Project management

Analytical thinking

Time management

Decision making

Presentation skills

Quality system knowledge

Regulatory awareness

AI/automation exposure

Education

Bachelor’s degree in Engineering or Science

Tools

Word

Excel

PowerPoint

Project

Job description

Omnicell seeks a Product Quality Engineer II to join the Quality team and ensure product compliance across design, development, and post-market phases. You will drive change control, review complaints, analyze data, and coordinate with cross-functional teams to meet regulatory requirements.

The role requires strong analytical skills, effective communication, and a proactive approach to risk management and process improvements within a fast-paced setting.