Sr. quality assurance engineer

Support the implementation, maintenance, and continuous improvement of the Quality Management System (QMS) at Conceivable Life Sciences. You'll work closely with the QA Manager to ensure compliance across the AURA platform and laboratory operations, driving quality from documentation through audit execution.

KEY RESPONSIBILITIES AND DUTIES

Support the development, review, and maintenance of QMS documentation, including SOPs, work instructions, forms, and records in alignment with ISO 9001, ISO 13485, and ISO 14971. Assist in the planning and execution of internal audits, including preparation of audit schedules, checklists, and follow-up on corrective actions. Manage and track CAPAs (Corrective and Preventive Actions), nonconformities, and deviations using root cause analysis tools such as 5 Whys and Ishikawa diagrams. Support ISO preparation and ongoing compliance activities, including documentation gap analysis and cross-referencing against regulatory checklists. Co...