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Quality Assurance Manager

2 months ago

East Anglia, United Kingdom Pertemps Network Group Full time

Job Title: Quality Assurance Manager

Job Summary:

Pertemps Network Group is seeking a highly skilled Quality Assurance Manager to lead our quality department and drive regulatory compliance in the medical equipment industry.

Key Responsibilities:

  • Quality Department Leadership: Manage the quality department, communicate expectations, lead external audits, and ensure adherence to ISO 13485 while setting and enforcing quality standards.
  • Quality Management System: Update and improve the Quality Management System to ensure compliance with regulatory requirements.
  • Automated Testing: Implement automated testing to identify and resolve non-conformances.
  • Production Area Management: Maintain cleanliness and traceability in production areas and review compliance with regulatory requirements.

Requirements:

  • Regulatory Knowledge: Knowledge of ISO 13485, UKCA, and MDR standards with over 5 years' experience in a supervisory quality role.
  • Quality Systems: Experience in ISO quality systems (9001, 13485), preferably in the medical field, with internal auditor training in ISO standards.
  • Engineering Background: Engineering background with metalwork and plastic components within an SME environment, preferred.
  • Self-Motivation: Self-motivated with strong attention to detail.
  • Computer Applications: Proficient in computer applications.

Additional Responsibilities:

Collaborate closely with directors and staff to ensure quality compliance and contribute to the overall success of production and quality initiatives.