Sr. Quality Engineer bei Omnicell Enterprise
Omnicell Enterprise · Pittsburgh, Vereinigte Staaten Von Amerika · Hybrid
- Senior
- Optionales Büro in Pittsburgh
At Omnicell, the Senior Quality Engineer plays a key role in making sure our Corrective and Preventive Action (CAPA) process truly solves problems—and keeps them from coming back. This person leads both the CAPA and Quality Management System (QMS) audit efforts, digs into data to uncover insights, and ensures we stay aligned with regulatory standards.
We’re looking for someone who’s not just detail-oriented and analytical, but also a strong communicator and problem-solver. The ideal candidate is adaptable and thrives in a collaborative environment.
This role is central to driving continuous improvement across the organization. You’ll work closely with senior leaders and cross-functional teams to support our quality strategy, enhance processes, and elevate product quality. Success here means having deep expertise in quality systems, the confidence to lead, and the ability to influence decisions that shape our products and how we build them.
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.
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 or science or quality management discipline
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
Experience working with QMS internal audits
Work Conditions:
- Onsite hybrid structure (2-3 days onsite)
- May travel up to 10%
