Product Quality Engineer II: Change Control & Compliance

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

Job summary

Omnicell, Inc. is seeking a Product Quality Engineer II to join the Quality team. You will partner with product management, engineering, and customer-facing groups to ensure design, development, and post-market activities meet regulatory standards.

The role emphasizes change control leadership, complaint review, data analysis, and continuous improvement across the product lifecycle. The ideal candidate brings strong communication and problem-solving skills, is detail-oriented, and can work

Qualifications

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

Responsibilities

• Lead change control and design activities including defect management and engineering escalation processes.
• Review and approve verification and validation protocols, plans, and records for product development and changes.
• Provide quality support for product lifecycle processes and ensure compliance with regulatory standards.
• Lead complaint reviews, trend monitoring, risk assessment, and CAPA coordination across functions.
• Triage and log out-of-box quality issues and potential safety concerns; assist post-market safety assessments.
• Drive MDR processes and manage field actions and recalls in collaboration with regulators and teams.
• Support internal QMS documentation and regulatory standards; drive continuous improvement initiatives.

Skills

Communication

MS Office

Project management

Analytical

Quality systems

Regulatory compliance

Cross-functional collaboration

Problem-solving

Education

Bachelor’s degree in Engineering or Science

Job description

Omnicell, Inc. is seeking a Product Quality Engineer II to join the Quality team. You will partner with product management, engineering, and customer-facing groups to ensure design, development, and post-market activities meet regulatory standards.

The role emphasizes change control leadership, complaint review, data analysis, and continuous improvement across the product lifecycle. The ideal candidate brings strong communication and problem-solving skills, is detail-oriented, and can work