Quality Improvement & Inspection Lead
Lead quality improvement projects for care providers, conducting mock inspections, assessing risks, advising senior leaders and helping services embed sustainable improvements across diverse care settings.
We are a dedicated, quality-driven organization committed to delivering excellence across all our operational, engineering, and manufacturing processes. Our Quality Assurance (QA) team ensures that our systems, products, and services meet the highest standards of reliability, continuous improvement, and regulatory compliance under our ISO 9001 Quality Management System (QMS).
We are seeking a highly experienced, detail-oriented, and autonomous Lead ISO 9001 Internal Auditor with a minimum of 10 years of audit experience to fully own and lead our QMS internal auditing program. In this 20% part-time role (~8 hours per week), you will act as our primary ISO 9001 audit authority, driving risk-based auditing, root cause analysis, non-conformance management, and external audit readiness across the organization.
As the Lead ISO 9001 Internal Auditor, you will be responsible for end-to-end planning, execution, and oversight of our QMS internal audit program. Working closely with process owners and QA leadership, you will evaluate business processes against ISO 9001 standards, guide corrective actions (CAPA), and ensure our organization maintains continuous readiness for registrar certification and surveillance audits.
Carnegie Robotics is an Equal Opportunity Employer that welcomes applications from all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, or status as a covered veteran in accordance with applicable laws and Carnegie Roboticsβ employment policies.
Lead quality improvement projects for care providers, conducting mock inspections, assessing risks, advising senior leaders and helping services embed sustainable improvements across diverse care settings.
Lead quality improvement projects for care providers, conducting mock inspections, advising senior leaders on governance, and turning findings into practical action plans and lasting improvements across diverse care settings.
Own clinical regulatory strategy and documentation for medical devices across the EU, FDA, and UK, including clinical evaluations, study submissions, post-market evidence, and guidance to hardware and software teams.
Plans and conducts ISO 9001, 14001 and 45001 management system audits, delivering certification assessments, accurate reporting and strong client service while maintaining auditor registrations and industry knowledge.
Plans and conducts ISO 9001, 14001 and 45001 management system audits, delivering certification assessments, accurate reporting and effective client relationships while maintaining auditor registrations and industry knowledge.