Total Quality Management Lead

4 weeks ago


Cardiff, Cardiff, United Kingdom Linea Resourcing - STEM Recruiter Full time
Job Description

We are searching for a skilled Regulatory Compliance Expert to join our team at Linea Resourcing. The successful candidate will be responsible for ensuring our business meets the highest standards of quality and regulatory compliance.

Key Responsibilities:

  • Develop, implement, and maintain QMS documentation and processes to ensure compliance with regulatory requirements.
  • Conduct and support internal and external audits to verify adherence to quality standards.
  • Provide guidance and training on relevant regulatory requirements and standards to engineering, production, and design teams.
  • Manage CAPA activities and associated reporting to ensure effective implementation of corrective actions.

Requirements:

  • Prior experience in managing QMS systems in a medical device or pharmaceutical setting.
  • Detailed knowledge of ISO 13485, MDD, and FDA regulations.
  • Excellent communication and project management skills.

Benefits:

  • An attractive annual salary of £44,800.
  • A 12% bonus based on individual and company performance.
  • A flexible hybrid working arrangement.
  • A competitive benefits package.
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