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

1. 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.
2. Assist in the planning and execution of internal audits, including preparation of audit schedules, checklists, and follow-up on corrective actions.
3. Manage and track CAPAs (Corrective and Preventive Actions), nonconformities, and deviations using root cause analysis tools such as 5 Whys and Ishikawa diagrams.
4. Support ISO preparation and ongoing compliance activities, including documentation gap analysis and cross-referencing against regulatory checklists.
5. Coordinate with Leaders across departments to ensure QMS adherence, collect KPI data, and drive process improvement initiatives.
6. Assist in SOC2 policy review and compliance monitoring through Vanta, identifying gaps and supporting remediation efforts.
7. Support the maintenance and improvement of the QC Health ScoreCard system, monitoring checklist adherence across laboratory operations.
8. Participate in management review meetings and contribute to executive reporting on quality metrics and status updates.
9. Help manage document control processes, including version control, authorization workflows, and archiving.
10. Support training initiatives related to quality processes and regulatory requirements across the organization.

EDUCATION AND EXPERIENCE REQUIREMENTS

• Bachelor's degree in Engineering (Industrial, Biomedical, Chemical, or related field) or equivalent experience in quality management.
• 2-4 years of experience in quality engineering or quality assurance roles, preferably in medtech, biotech, or regulated industries.
• Working knowledge of ISO 9001, ISO 13485, and experience with QMS implementation and maintenance.
• Familiarity with audit processes (internal and external) and corrective/preventive action management.