Senior Quality Engineer – Med Device (ISO 13485)

Omnicell; Cranberry Township (Butler County); On-site; USD 80,000 - 115,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k) with match

PTO

Job summary

Omnicell seeks a seasoned Quality & Regulatory professional to lead defect management, design control, and post‑market activities for medical devices. You will coordinate cross‑functional teams across engineering, product management, and quality to ensure timely resolution of issues and robust documentation of changes.

You will drive VER/ validation processes, maintain theDevice Master Record, uphold ISO 9001/13485 compliance, and contribute to continuous improvement through CAPA and risk

Qualifications

• Bachelor’s degree in Engineering or Science discipline.
• 5+ years in Engineering, Quality or related technical professional experience.
• Experience in product development and/or maintenance.
• Experience in process development.
• Experience working in a regulated environment (i.e. ISO 9001, ISO 13485 or FDA QMSR).

Responsibilities

• Lead defect management and engineering escalation processes, ensuring timely identification, resolution, and reporting of product issues.
• Drive review and approval of design and service verification and validation protocols for product changes and lifecycle processes.
• Manage cross-functional teams in product change control processes with comprehensive documentation of modifications.
• Own maintaining and updating the Device Master Record (DMR) for assigned product lines during post-market changes.
• Ensure alignment of design outputs with inputs and compliance with internal protocols.
• Act as lead liaison between engineering, product management, and quality teams to integrate quality early in product design.

Skills

QMS documentation

Regulatory standards

Jira

SDLC

Root cause analysis

Project management

Leadership

Communication

Quality metrics

CAPA

Education

Bachelor’s degree in Engineering or Science

Tools

Jira

Job description

Omnicell seeks a seasoned Quality & Regulatory professional to lead defect management, design control, and post‑market activities for medical devices. You will coordinate cross‑functional teams across engineering, product management, and quality to ensure timely resolution of issues and robust documentation of changes.

You will drive VER/ validation processes, maintain theDevice Master Record, uphold ISO 9001/13485 compliance, and contribute to continuous improvement through CAPA and risk