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Senior Quality Manager

2 months ago

London, Greater London, United Kingdom Athsai Full time

About the Role

Athsai is seeking a highly skilled Senior Quality Manager to lead our Medical Devices team. As a key member of our organization, you will be responsible for ensuring the highest quality standards in our manufacturing processes.

Key Responsibilities

  • Collaborate with cross-functional teams to develop and implement quality strategies that meet regulatory requirements and company standards.
  • Develop and maintain quality management systems, including CAPA, PFMEA, and Control Plans.
  • Lead the development and implementation of Lean Six Sigma methodologies to improve manufacturing processes.
  • Provide guidance and support to project quality engineers, ensuring they have the necessary resources and training to perform their duties effectively.
  • Approve IQ, OQ, PQ, and TMV or Software Validation protocols and reports.
  • Conduct risk assessments and develop mitigation strategies to ensure the highest level of quality in our products.
  • Develop and maintain relationships with key stakeholders, including project leaders, manufacturing engineering teams, and other functional partners.
  • Ensure compliance with regulatory requirements, company policies, and industry standards.
  • Develop and implement training programs to ensure that all employees understand their roles and responsibilities in maintaining quality standards.

Requirements

  • Proven experience in quality management, preferably in the medical devices industry.
  • Strong knowledge of quality management systems, including CAPA, PFMEA, and Control Plans.
  • Experience with Lean Six Sigma methodologies and their application in manufacturing processes.
  • Excellent communication and leadership skills, with the ability to collaborate with cross-functional teams.
  • Strong analytical and problem-solving skills, with the ability to identify and mitigate risks.
  • Ability to develop and maintain relationships with key stakeholders.
  • Strong understanding of regulatory requirements and industry standards.