Quality Assurance Associate

We're looking for a Quality Assurance & Document Control professional to support and enhance the Quality Management System across multiple manufacturing facilities.

Working closely with the wider Quality team, you'll help maintain compliance with FDA Quality System Regulations while ensuring alignment with ISO 9001 and ISO 13485 standards.
This role requires autonomy, strong organisational ability, and the confidence to lead audits at various levels.

• Conduct routine internal audits across manufacturing sites
• Assess processes, procedures, and documentation against internal quality standards
• Identify improvement opportunities and recommend corrective actions
• Host and support customer audits
• Coordinate cross-functionally to gather information and address findings
• Maintain strong customer relationships throughout the audit process
• Prepare for and participate in ISO 9001 / ISO 13485 certification audits
• Ensure compliance across all required areas
• Work with relevant departments to resolve non-conformities
• Track quality performance indicators and trends
• Present findings to senior leadership
• Identify training gaps and support quality-related training initiatives
• Communicate effectively with leadership, colleagues, and global teams
• Collaborate with Engineering, Manufacturing, and other functions to uphold quality standards

Requirements

• Excellent written and verbal communication skills
• Experience in document control and change control
• Experience with batch/product release processes
• Strong knowledge of Microsoft Office and quality-related software/tools
• Understanding of audit methods and inspection processes
• Knowledge of:
  • ISO 14971 (risk management for medical devices)
  • IEC 62304 (medical device software)
  • GxP, GMP, FMEA, HACCP
  • Relevant medical device & pharmaceutical standards

• Bachelor's or Associate Degree in:
  Life Science, Chemistry, Engineering, Business, Science, or related field
• Ability to obtain/maintain Lead Auditor Certification (ISO 19011 or similar)
• Minimum:
  Bachelor's degree + experience in Life Sciences, Medical Devices, or similar regulated industries
• At least 2 years' experience in quality assurance or related field
• Working knowledge of:
  • Change Control
  • Document Control
  • 8D corrective action methodology
• Ability to understand complex documentation such as:
  QM, DHF, DMR, DHR, PMS, IFU, PSUR, etc.
• Strong organisational and project coordination skills
• Proficient with Windows, MS Office (Teams, Excel, Visio), and task-tracking tools (Planner, To Do, etc.)
• Strong teamwork skills and ability to deliver training/presentations at all levels