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Head of Quality Assurance

3 months ago

Derby, Derby, United Kingdom Umbilical Life Full time

Quality Assurance Manager

Company Overview

We are looking for a committed Quality Assurance Manager to join our team at Umbilical Life. This role is essential in maintaining the utmost quality standards and ensuring adherence to regulatory requirements in our medical device production.

Key Responsibilities

  • Oversee Quality Investigation Reports and implement CAPA strategies.
  • Continuously revise quality documentation, including Quality Manuals, Standard Operating Procedures (SOPs), and Audit Reports.
  • Drive process enhancement initiatives and lead the internal audit team.
  • Collaborate with production, storage, and maintenance teams to uphold quality benchmarks.
  • Assist in the validation of sterile manufacturing protocols.
  • Manage and facilitate external audits.
  • Ensure compliance with on-site temperature regulations.
  • Validate machinery, processes, and new product introductions.
  • Lead Hazard Analysis Critical Control Point (HACCP) teams to guarantee food safety compliance.

Performance Objectives

  • Ensure adherence to all applicable legislation.
  • Meet Quality Site Metrics objectives.
  • Promptly address risks and challenges.
  • Effectively manage product recalls.
  • Maintain ongoing accreditation with relevant bodies (Notified Bodies, ISO, BRC, GDP, etc.).
  • Achieve successful evaluations from clients and regulatory entities.

Qualifications and Experience

Essential:

  • A minimum of 3 years in Quality Management within a regulated healthcare sector.
  • Knowledge of Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), Medical Device regulations, ISO 9001, and ISO 13485.
  • Excellent problem-solving abilities and teamwork skills.

Desirable:

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

If you are passionate about quality assurance and ready to contribute to our mission, we encourage you to consider this opportunity.