Senior Quality Engineer: Change Control & Risk Lead

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

Benefits offered by this job

Medical, dental and vision plans

Retirement plans with matching

Paid time off

Wellness programs

Life insurance

Disability insurance

Job summary

Omnicell, Inc. is seeking a quality-focused engineer to lead post-market involvement, defect management, and design verification across product lines in a regulated healthcare environment.

You will drive CAPA, MDR processes, and cross-functional collaboration with engineering, product management, and regulatory teams. This role emphasizes maintaining ISO 9001/13485 compliance, robust risk management, and lifecycle product changes from initiation to post-market support.

Qualifications

• Bachelor’s degree in Engineering or Science is required.
• 5+ years in Engineering, Quality or related technical professional experience.
• Experience in product development and/or maintenance in a regulated environment (ISO 9001, ISO 13485 or FDA QMSR).
• Experience leading cross-functional teams and managing product changes from initiation through post-market stages.
• Strong problem-solving and leadership abilities.

Responsibilities

• Lead the execution of 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, with a focus on product changes and lifecycle processes.
• Manage cross-functional teams in product change control processes and ensure comprehensive documentation of product modifications.
• Maintain and update the Device Master Record (DMR) for assigned product lines during post-market changes.
• Ensure alignment of design outputs with inputs, addressing discrepancies and ensuring compliance with internal protocols.
• Act as the lead liaison between engineering, product management, and quality teams to integrate quality considerations in the design phase.
• Independently process and triage out-of-box quality issues, conducting root cause analyses and driving corrective actions.
• Lead post-production safety risk assessments and implement solutions to mitigate safety concerns.
• Drive the Medical Device Reporting (MDR) process, coordinating with regulatory bodies and managing field actions and recalls.
• Present safety and risk management updates during Safety Risk Management Board Meetings, with responsibility for product-specific risks.
• Lead quality improvement projects to optimize processes, reduce defects, and improve customer satisfaction.
• Ensure adherence to ISO 9001, ISO 13485, and other regulatory standards, acting as a subject matter expert for compliance.
• Implement and analyze quality metrics and generate reports to monitor performance and drive improvements.
• Conduct internal audits and manage CAPA to maintain compliance and drive continuous improvement.

Skills

QMS knowledge

Root cause analysis

Statistical analysis

Project management

Cross-functional collaboration

Leadership

Communication

Education

Bachelor’s degree in Engineering or Science

Tools

Jira

Job description

Omnicell, Inc. is seeking a quality-focused engineer to lead post-market involvement, defect management, and design verification across product lines in a regulated healthcare environment.

You will drive CAPA, MDR processes, and cross-functional collaboration with engineering, product management, and regulatory teams. This role emphasizes maintaining ISO 9001/13485 compliance, robust risk management, and lifecycle product changes from initiation to post-market support.