Responsibilities:

• Quality Management Systems (QMS):
  • Establish, implement, and maintain a robust QMS aligned with industry standards and ensuring compliance.
  • Scale the QMS to accommodate company growth and evolving product needs.
• Risk Management:
  • Implement and oversee a comprehensive risk management program to identify and mitigate risks.
• Verification and Validation (V&V) & Quality Control (QC):
  • Collaborate with R&D to develop effective V&V protocols and reports.
  • Ensure product compliance with requirements and regulations.
  • Establish and manage QC processes for manufacturing.
  • Implement statistical process control methodologies.
• Supplier Quality Management:
  • Develop and maintain a supplier quality management program.
  • Conduct regular supplier audits.
• Clinical Quality Oversight:
  • Collaborate with Clinical Operations to ensure clinical quality oversight and adherence to GCP standards.
  • Streamline processes for faster time to market approval.
• Continuous Improvement:
  • Drive a culture of continuous improvement.
  • Implement and monitor key performance indicators.
• Training and Development:
  • Develop and deliver training programs.
  • Foster a culture of quality and regulatory compliance.
• Audit Management:
  • Plan and manage internal and external audits.
  • Implement corrective and preventive actions.
• Document Control:
  • Oversee document control processes to ensure accuracy, completeness, and accessibility.
  • Implement electronic document management systems.
• Reporting and Communication:
  • Provide regular reports on quality affairs.
  • Communicate effectively with regulatory agencies, notified bodies, and external partners.

Qualifications:

• Bachelor’s degree in a relevant field; advanced degree preferred.
• Proven experience in the medical device industry, with a focus on structural heart devices.
• Experience in both large corporations and smaller startups.
• Extensive experience overseeing QA activities in R&D, manufacturing, supplier management, and clinical quality.
• In-depth knowledge of FDA requirements and a successful track record in obtaining FDA clearance.
• Successful track record in achieving and maintaining ISO certifications.
• Strong leadership and interpersonal skills.
• Excellent written and verbal communication skills in English.
• Experience in overseeing clinical quality and working closely with R&D and Clinical Operations.
• Willingness to travel as required.