Quality Assurance Specialist

Position Summary:

The QA Specialist will be responsible for ensuring that all quality assurance activities are compliant with ISO 13485, MDR 2017/745, and applicable FDA requirements. You’ll play a key role in supporting our QMS, managing CAPAs, document control, supplier quality, and internal audits while contributing to a culture of continuous improvement.

Key Responsibilities:

• Support and maintain the Quality Management System (QMS) in compliance with ISO 13485 and MDR 2017/745.
• Prepare and maintain QA documentation, including SOPs, work instructions, and forms.
• Manage non-conformances (NCs), corrective and preventive actions (CAPAs), and change control processes.
• Conduct internal audits and support external audits (Notified Bodies, suppliers, etc.).
• Assist in supplier qualification, evaluation, and ongoing performance monitoring.
• Perform quality reviews of batch records, device history files, and final product release.
• Participate in risk management activities and support technical documentation.
• Support training activities related to quality processes and regulatory compliance.
• Work cross-functionally with R&D, manufacturing, and regulatory teams.
• Continuously seek process improvements and ensure adherence to applicable regulations.

Requirements:

• Bachelor’s degree in Life Sciences, Engineering, or related field (or equivalent experience).
• 2 years of experience in QA within the medical device industry (Class IIa preferred).
• Strong knowledge of ISO 13485, MDR, and QMS principles.
• Experience with document control, CAPA, internal audits, and risk management.
• Attention to detail with strong organizational and communication skills.
• Proactive, self-motivated, and comfortable working in a fast-paced small team environment.

Preferred Qualifications:

• Experience in a startup or small company setting.
• Familiarity with FDA 21 CFR Part 820.
• Audit experience (internal or external).
• Working knowledge of eQMS tools.