Product Quality Engineer II: Change Control & Compliance

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

Job summary

Omnicell in Cranberry Township, PA, is seeking a Product Quality Engineer II to partner with product management, engineering, and customer-facing teams to ensure designs meet regulatory and post-market requirements.

You will lead change control, review verification and validation plans, manage complaint investigations, and drive continuous improvement across the product lifecycle, aligning with ISO 9001 and ISO 13485 standards.

Qualifications

• Bachelor's degree in Engineering or Science required.
• Experience in regulated environments (ISO 9001/13485 or FDA) preferred.
• Experience with product development and maintenance.

Responsibilities

• Lead change control and design processes for product development and post-market changes.
• Review and approve verification/validation protocols and records.
• Lead complaint reviews, trend monitoring, risk assessment and CAPAs.
• Manage MDR reporting, field actions, and recalls as applicable.
• Ensure QMS compliance and drive continuous improvement across lifecycle.

Skills

Strong communication

Project management

Analytical mindset

Cross-functional collaboration

Proficiency with MS Office

Quality systems knowledge

Problem solving

Time management

Documentation accuracy

Regulatory awareness

Adaptability

Attention to detail

Education

Bachelor's degree in Engineering or Science

Job description

Omnicell in Cranberry Township, PA, is seeking a Product Quality Engineer II to partner with product management, engineering, and customer-facing teams to ensure designs meet regulatory and post-market requirements.

You will lead change control, review verification and validation plans, manage complaint investigations, and drive continuous improvement across the product lifecycle, aligning with ISO 9001 and ISO 13485 standards.