Quality Engineer, QMS

What success looks like:

• Support of a 21 CFR Part 820 and ISO 13485 compliant quality management system (QMS) including drafting, revising, reviewing and approving procedures
• Work with internal stakeholders on the qualification and approval of suppliers. Work with suppliers to address changes, nonconformances, and implement corrective actions, as necessary
• Perform supplier qualification activities, including evaluations and audits
• Maintain QMS processes in compliance as assigned by QA leadership including but not limited to nonconformity management, CAPA management, deviation management, employee training.
• Maintains CAPAs and Corrections in compliance with respect to due dates, ensures tasks are completed on time and items are recorded appropriately by responsible personnel.
• Ensures company is compliant with training completion and on time training completion by following up with personnel who are not compliant
• Ensures deviations are opened and closed in a timely manner and documentation is compliant
• Improve processes for compliance, implementing the least burdensome approach
• Manage scheduling, coordination, and meetings for audits with external parties and internal Subject Matter Experts. Manage audit results/reports, and any actions that arise from audits
• Manage all tasks related to customer and external audits

What you will bring:

• Support of a 21 CFR Part 820 and ISO 13485 compliant quality management system
• Experience with supplier qualification and auditing
• Knowledge of CAPA, nonconformity, and deviation management
• Strong organizational and communication skills
• Ability to manage external audits and audit schedules