Quality Assurance Engineer, CAPA & Internal Audit

The Quality Assurance team partners across Omnicell to consistently fulfill the needs of our customers by providing end-to-end quality support for our products and services through the execution of our QMS processes.

The Quality Engineer IV at Omnicell is responsible for ensuring our Corrective and Preventive Action (CAPA) process is effectively solving problems so they don’t recur. This role involves leading the CAPA and QMS Audit processes, analyzing data, and maintaining compliance with regulatory standards. The ideal candidate will be versatile, analytical, and detail-oriented, with strong communication and problem-solving skills.

The Quality Engineer IV plays a pivotal role in driving continual improvement, while supporting the overall quality strategy, working closely with senior leadership and cross-functional teams to ensure compliance, optimize processes, and improve product quality. This position requires expert-level understanding of quality processes, strong leadership, and the ability to influence key decisions affecting the company's products and processes.
 

*PLEASE NOTE: This is an hybrid role in Pittsburgh, PA which requires staff to work in office 2-3 days per week. 

Responsibilities:

Capa:

• Oversee and lead the Corrective Action Board (CAB) to ensure issues are funneled into the CAPA process
• Facilitate Root Cause Analysis training across Omnicell to promote a culture of problem solving at all levels
• Ensure outcomes of CAPAs are effective and provide KPI’s demonstrating effectiveness
• Manage and update CAPA records across all product lines, ensuring accurate documentation throughout the entire lifecycle 

Qms Audits:

• Lead the scheduling of all QMS internal audits and act as lead auditor
• Mentor and train internal audit team
• Champion Omnicell’s multi-site QMS external certification to ISO standards
• Manage and update audit records across all product lines, ensuring accurate documentation throughout the entire lifecycle 

Compliance And Continuous Improvement:

• Champion continuous improvement initiatives, identifying opportunities to enhance and optimize internal processes
• Lead external audits and regulatory inspections, ensuring full compliance with ISO, FDA, and other relevant regulatory bodies
• Develop and implement advanced quality metrics, presenting findings to senior leadership and driving actions to meet key performance indicators (KPIs)

Required Knowledge & Skills:

• Expert-level knowledge of QMS processes and regulatory standards (ISO 13485, FDA, etc.).
• Demonstrated ability to lead large-scale CAPA projects, including product and process improvement projects
• Strong leadership and decision-making skills, with the ability to influence cross-functional teams and senior leadership
• Expertise in quality tools and methodologies, such as RCA methodologies, Six Sigma, etc.
• Exceptional communication skills and the ability to lead complex regulatory audits and inspections 

Basic Qualifications:

• Minimum 6 years’ professional experience in a Quality Assurance role
• Bachelor’s degree in engineering or science or quality management discipline
• Experience working in a regulated environment (i.e. ISO 9001, ISO 13485 or FDA regulated)
• Experience working with corrective and preventive actions
• Experience working with QMS internal audits 

Preferred Qualifications:

• Auditor certification in ISO13485/ISO9001 and/or CQA

Work Conditions:

• Onsite hybrid structure (2-3 days onsite)
• May travel up to 10%