Manager of Quality Assurance

4 weeks ago


Derby, Derby, United Kingdom Umbilical Life Full time

Quality Assurance Manager

Company Overview

At Umbilical Life, we are committed to excellence in the medical device sector. We are currently in search of a Quality Assurance Manager to oversee our quality management processes and ensure compliance with industry standards.

Key Responsibilities

  • Oversee the management of Quality Investigation Reports and Corrective and Preventive Action (CAPA) plans.
  • Continuously update and maintain quality documentation, including Quality Manuals, Standard Operating Procedures (SOPs), and Audit Reports.
  • Lead initiatives for process enhancements and manage the internal audit team.
  • Collaborate with production, warehouse, and maintenance teams to uphold quality standards.
  • Assist in the validation of sterile manufacturing processes.
  • Supervise and facilitate external audits.
  • Monitor on-site temperature controls to ensure compliance.
  • Validate equipment, processes, and new product introductions.
  • Lead Hazard Analysis Critical Control Point (HACCP) teams to maintain food safety protocols.

Performance Objectives

  • Ensure adherence to all applicable regulations and standards.
  • Meet Quality Site Metrics targets consistently.
  • Promptly address risks and issues as they arise.
  • Effectively manage product recall processes.
  • Maintain ongoing accreditation with relevant bodies (Notified Bodies, ISO, BRC, GDP, etc.).
  • Achieve favorable audit outcomes from customers and regulatory agencies.

Qualifications and Skills

Essential:

  • A minimum of 3 years of experience in Quality Management within a regulated healthcare environment.
  • Proficient knowledge of Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), Medical Device regulations, ISO 9001, and ISO 13485.
  • Demonstrated problem-solving abilities and strong teamwork orientation.

Desirable:

  • Familiarity with HACCP, BRC, ISO 14644, and ISO 14001 standards.

We value individuals who are passionate about quality and eager to contribute to our mission.



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