Product Quality Engineer II – Change Control & Compliance

RXinsider LTD.; Cranberry Township (Butler 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 is seeking a Product Quality Engineer II to partner with product management, engineering, and customer-facing teams to ensure our products meet design, development, and post-market requirements through the QMS. The role leads product change control, reviews verification and validation protocols, maintains the Device Master Record, and drives quality improvement across the lifecycle.

Expect a collaborative, detail‑oriented professional with strong communication skills, capable of working

Qualifications

• Bachelor’s degree in engineering or sciences.
• 2+ years in engineering, quality or related field.
• Strong cross-functional communication skills.
• Experience in regulated environments (ISO 9001/13485 or FDA).
• Familiarity with SDLC, 21 CFR Part 11, IEC 62304.

Responsibilities

• Execute defect management and engineering escalation.
• Review and approve verification and validation protocols.
• Lead product change control processes.
• Maintain Device Master Record through releases.
• Support quality metrics and improvement initiatives.

Skills

Communication skills

Project management

Organizational skills

Time management

Self-starter

Analytical mindset

MS Office proficiency

Jira

Decision making

Education

Bachelor's degree in Engineering or Science

Tools

Jira

MS Office

Job description

Omnicell is seeking a Product Quality Engineer II to partner with product management, engineering, and customer-facing teams to ensure our products meet design, development, and post-market requirements through the QMS. The role leads product change control, reviews verification and validation protocols, maintains the Device Master Record, and drives quality improvement across the lifecycle.

Expect a collaborative, detail‑oriented professional with strong communication skills, capable of working