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Head of Quality Assurance

Salary undisclosed

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We are seeking an experienced and dynamic Head of Quality Assurance to lead the Quality Assurance (QA) team of a leading Medical Device Manufacturer Client of ours. This role is critical in ensuring that our products meet all regulatory requirements and quality standards, and in driving continuous improvement initiatives across the organization. The role would be a 1 year Temp to Perm contract able to be worked Hybrid or Remote dependant on the candidates location.

Key Responsibilities:

  • Leadership: Provide strategic direction and leadership to the QA team, fostering a culture of quality and compliance.
  • Regulatory Compliance: Ensure all products and processes comply with FDA, ISO, and other relevant regulatory standards.
  • Quality Management Systems: Oversee the development, implementation, and maintenance of Quality Management Systems (QMS).
  • Continuous Improvement: Drive continuous improvement initiatives to enhance product quality and operational efficiency.
  • Risk Management: Identify and mitigate quality-related risks through proactive risk management strategies.
  • Audits and Inspections: Lead internal and external audits, ensuring readiness and compliance with regulatory inspections.
  • Collaboration: Work closely with cross-functional teams, including R&D, Manufacturing, and Regulatory Affairs, to ensure quality is integrated into all aspects of product development and production.
  • Training and Development: Develop and implement training programs to ensure all employees are knowledgeable about quality standards and practices.

Qualifications:

  • Education: Bachelor’s degree in Engineering, Life Sciences, or a related field. Advanced degree preferred.
  • Experience: Minimum of 10 years of experience in Quality Assurance within the medical device industry, with at least 5 years in a leadership role.
  • Knowledge: In-depth knowledge of FDA regulations, ISO standards, and other relevant quality and regulatory requirements.
  • Skills: Strong leadership, communication, and interpersonal skills. Proven ability to lead and motivate teams.
  • Problem-Solving: Excellent analytical and problem-solving abilities, with a track record of implementing effective quality improvement initiatives.

Interested candidates are invited to submit their resume and cover letter and expect to hear back as soon as possible.

Kind regards,