Senior Quality Engineer

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).
• 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,
• Exceptional communication skills and the ability to lead complex regulatory audits and inspections.
• Auditor certification in ISO13485/ISO9001 and/or CQA
• Minimum 6 years’ professional experience in a Quality Assurance role
• Bachelor’s degree in engineering or science or quality management discipline
• Experience in process development  
• 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
• Onsite hybrid structure (2-3 days onsite)
• May travel up to 10%

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,
• Exceptional communication skills and the ability to lead complex regulatory audits and inspections.

• QMS auditor certification in ISO13485/ISO9001 and/or CQA

Basic Qualifications:

• Minimum 6 years’ professional experience in a Quality Assurance role

• Bachelor’s degree in engineering, science or quality management discipline or 10+ equivalent years of experience

Preferred Qualifications:

• Experience in process development  
• Experience working in a regulated environment (i.e. ISO 9001, ISO 13485 or FDA regulated)

• Experience working with corrective and preventive actions

Work Conditions:

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