The Quality Assurance Specialist is responsible for supporting the Quality Management System throughout the organization in support of product maintenance, development, and growth. The Quality Assurance Specialist will, with direction, be responsible for document management, QMS training, complaint and CAPA management.

• Own and lead the document management process, including configuration management.
• Work cross-functionally to lead the complaint management process, including investigations, customer interactions, and reporting to management
• Lead the CAPA management process to work cross functionally to identify root causes, and implement remediations
• Lead the QMS training (and retraining) to ensure compliance with US and International requirements.
• Assist in the evaluation and qualification of suppliers.
• Complete Quality System Audits (internal and external audits) to ensure compliance.

• Communicates, cooperates, and consistently functions professionally and harmoniously with all levels of supervision, co-workers, patients, visitors, and vendors.
• Demonstrates initiative, personal awareness, professionalism and integrity, and exercises confidentiality in all areas of performance.
• Participation in regulatory audits
• Excellent written and oral communication skills

• Bachelor’s degree in relevant field (or equivalent experience, i.e. Associates Degree with 3 years of experience)
• Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820.
• Knowledge of EU Medical Device Regulation (MDR), ISO13485, ISO 14971, and IEC 62034 preferred.
• 2 - 4 years working in a regulated industry (FDA and Software as a Medical Device preferred)