Quality Assurance Auditor II (Medtech)

TL;DR

Quality Assurance Auditor II (Medtech): Leads quality audits and assessments of procedures, systems, and data to ensure regulatory compliance and high service standards with an accent on root cause analysis and CAPA management. Focus on supporting various audit types and implementing process improvements within the audit program.

Location: Must be based in Europe

Company

hirify.global transforms lives by unlocking better evidence through advancing clinical science and building innovative technology to bring life-changing therapies to patients faster.

What you will do

• Plan, conduct, and report audits according to standard operating procedures.
• Track audit issues and CAPAs until closure, providing root cause guidance.
• Support all audit/inspection types, including internal, external, vendor, and regulatory inspections.
• Conduct QA review of source documents and case report forms for accuracy.
• Support external quality audits and facilitate quality training of peers.

Requirements

• Bachelor’s degree, preferably in life sciences, trial or quality management, or computer science.
• 3+ years of experience in Quality Assurance, Auditing, Validation, and/or SDLC systems in regulated industries, preferably in Pharmaceutical, CRO, Biotech, or Medical device.
• Strong knowledge of Good Clinical Practices (GCP), ICH Guidelines, and Software Validation requirements.
• Knowledgeable of 21 CFR Part 11, Annex 11, and other applicable ERES regulations.
• Strong interpersonal, communication, documentation, and organizational skills.

Nice to have

• Quality and/or computer systems certification (e.g. ASQ Auditor).
• Understanding of medical and/or clinical trial terminology.

Culture & Benefits

• Competitive compensation and incentives.
• Private medical coverage and MetLife protection.
• Flexible time off.
• Engaging employee events and hybrid technology support.