QA Consultant (13485 / 27001)

139094
  • Competitive
  • London, United Kingdom
  • Contract

Job Title: QA Consultant (13485 & 27001)

Duration: 12-month Contract

Company Overview: My client is a leading player in the medical device industry, dedicated to developing innovative solutions that enhance patient care and improve healthcare outcomes. They are committed to maintaining the highest quality standards and regulatory compliance across all  products and services.

Position Overview: My client is seeking a skilled QA Consultant to join their team on a 12-month contract basis. The QA Consultant will play a vital role in ensuring compliance with regulatory requirements, particularly ISO13485, and will also be responsible for implementing and maintaining ISO27001 standards within the organization. The successful candidate will collaborate closely with cross-functional teams to uphold quality standards, mitigate risks, and drive continuous improvement initiatives.

Key Responsibilities:

  1. Lead the development, implementation, and maintenance of the Quality Management System (QMS) in accordance with ISO13485 requirements.
  2. Provide expertise and guidance on regulatory compliance matters related to medical device quality standards, including FDA regulations and international standards.
  3. Conduct internal audits and assessments to evaluate the effectiveness of QMS processes and identify areas for improvement.
  4. Develop and deliver training programs to enhance awareness and understanding of quality requirements across the organization.
  5. Act as the primary point of contact for external audits and regulatory inspections, ensuring readiness and facilitating successful outcomes.
  6. Lead the implementation and certification process for ISO27001 Information Security Management System (ISMS), including risk assessments, policy development, and security controls.
  7. Collaborate with stakeholders to establish and maintain documentation, including quality manuals, procedures, work instructions, and records.
  8. Investigate quality incidents, non-conformities, and customer complaints, implementing corrective and preventive actions to address root causes.
  9. Monitor key quality metrics and performance indicators, providing regular reports and insights to management.
  10. Stay current with industry trends, regulatory changes, and best practices to proactively identify opportunities for improvement.

Qualifications:

  • Bachelor's degree in a relevant field (e.g., Engineering, Life Sciences, Quality Management).
  • Minimum of 5 years of experience in Quality Assurance, preferably within the medical device industry.
  • Strong understanding of ISO13485 and ISO27001 standards, with prior experience implementing and maintaining these standards.
  • Knowledge of FDA regulations (21 CFR Part 820) and other relevant regulatory requirements.
  • Experience conducting internal audits and managing external audits/regulatory inspections.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively across functional teams.
  • Proven track record of driving continuous improvement initiatives and achieving results.
  • Relevant certifications (e.g., ASQ Certified Quality Auditor, ISO Lead Auditor) are preferred.

Please contact ryan.prouse@peoplewithchemistry.com with a copy of your CV and a short synopsis of your experience.

Ryan Prouse Recruiter

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