Head of Quality

Our client, a market leader in the medical device industry, is seeking a Head of Quality Assurance (QA) to lead and manage the quality assurance function for their high-risk medical devices portfolio. This is a key leadership role, responsible for establishing and maintaining the highest standards of quality compliance, ensuring that all products meet stringent regulatory and quality requirements across global markets.

The ideal candidate will have extensive experience in quality assurance for high-risk medical devices, including familiarity with ISO 13485, ISO 14971, EU MDR, and US FDA regulations. This position involves close collaboration with R&D, Regulatory Affairs, Manufacturing, and Supply Chain to drive a culture of quality throughout the organization and ensure product safety and efficacy.

Job Overview:

Our client, a market leader in the medical device industry, is seeking a Head of Quality Assurance (QA) to lead and manage the quality assurance function for their high-risk medical devices portfolio. This is a key leadership role, responsible for establishing and maintaining the highest standards of quality compliance, ensuring that all products meet stringent regulatory and quality requirements across global markets.

The ideal candidate will have extensive experience in quality assurance for high-risk medical devices, including familiarity with ISO 13485, ISO 14971, EU MDR, and US FDA regulations. This position involves close collaboration with R&D, Regulatory Affairs, Manufacturing, and Supply Chain to drive a culture of quality throughout the organization and ensure product safety and efficacy.

Key Responsibilities:

• Quality Management System (QMS) Oversight:
  Lead the development, implementation, and continuous improvement of the company’s Quality Management System (QMS) in compliance with ISO 13485, 21 CFR Part 820, and other applicable standards.

• Leadership and Team Management:
  Lead, mentor, and develop the Quality Assurance team, fostering a culture of high performance and continuous improvement.

• Regulatory Compliance:
  Ensure compliance with global regulatory requirements (e.g., FDA, EU MDR, and other relevant regulations) for high-risk medical devices. Act as the key point of contact for external audits and inspections.

• Internal and Supplier Audits:
  Oversee internal and external audits, including supplier quality audits, ensuring that all manufacturing partners and suppliers meet the required quality standards. Implement corrective actions and continuous improvement initiatives based on audit findings.

• Product Quality Oversight:
  Monitor product quality throughout the lifecycle, from development to post-market. Ensure that non-conformance issues are identified, documented, and resolved in a timely and compliant manner.

• Risk Management:
  Oversee risk management activities, including ensuring compliance with ISO 14971 for risk analysis, mitigation, and control throughout product development and manufacturing processes.

• CAPA Management:
  Lead the Corrective and Preventive Actions (CAPA) process, ensuring that root causes of issues are effectively identified and that appropriate actions are taken to prevent recurrence.

• Change Management:
  Ensure that all changes to processes, products, and equipment are controlled, reviewed, and implemented in accordance with applicable quality and regulatory requirements.

• Continuous Improvement:
  Drive continuous improvement initiatives to enhance product quality, reduce defects, and improve operational efficiencies within the organization.

• Post-Market Surveillance:
  Collaborate with Regulatory Affairs to ensure effective post-market surveillance, including complaint handling, field actions, and recall management when necessary.

• Collaboration with Cross-Functional Teams:
  Work closely with R&D, Regulatory Affairs, and Manufacturing to ensure that quality requirements are integrated into product design, development, and production processes.

Required Qualifications:

• Educational Background:
  Bachelor’s degree in engineering, life sciences, or a related field (Master’s degree preferred).

• Experience:

  • Minimum of 8-10 years in Quality Assurance in the medical device industry, with a focus on high-risk devices.
  • Proven experience in managing Quality Management Systems (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, and other global standards.
  • Experience leading and managing QA teams and working cross-functionally with key departments.

• Technical Expertise:

  • Strong understanding of regulatory requirements and quality standards, including EU MDR, FDA, ISO 14971, and other relevant industry regulations.
  • Familiarity with risk management processes for high-risk medical devices.

• Skills:

  • Strong leadership, communication, and interpersonal skills.
  • Ability to manage multiple projects, deadlines, and regulatory requirements simultaneously.
  • Analytical problem-solving skills with a strong attention to detail.

Required Qualifications:

• Educational Background:
  Bachelor’s degree in engineering, life sciences, or a related field (Master’s degree preferred).

• Experience:

  • Minimum of 8-10 years in Quality Assurance in the medical device industry, with a focus on high-risk devices.
  • Proven experience in managing Quality Management Systems (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, and other global standards.
  • Experience leading and managing QA teams and working cross-functionally with key departments.

• Technical Expertise:

  • Strong understanding of regulatory requirements and quality standards, including EU MDR, FDA, ISO 14971, and other relevant industry regulations.
  • Familiarity with risk management processes for high-risk medical devices.

• Skills:

  • Strong leadership, communication, and interpersonal skills.
  • Ability to manage multiple projects, deadlines, and regulatory requirements simultaneously.
  • Analytical problem-solving skills with a strong attention to detail.

How to Apply:

Interested candidates should submit their CV to a.brenner@panda.com