Quality Requirements:
Regulatory Compliance: Maintain an ISO 9001 or ISO 13485 certification, or operate under equivalent, applicable quality standards
Quality Management: Maintain a robust quality management system which clearly defines processes to ensure materials meet required specifications.
Risk Management: Implement effective risk controls and maintain reliable contingency plans to minimize the impact of potential supply interruptions.
Engineering & Technical Collaboration: Willingness and capability to collaborate on design for manufacturability (DFM), cost-reduction initiatives, and new product introduction (NPI).
Audit Readiness: Remain audit-ready and cooperate with scheduled or unannounced quality and compliance audits conducted by LeMaitre or Regulatory Agencies.
Sustainability & Ethical Practices: Commitment to environmentally responsible manufacturing and ethical business practices. Comply with applicable laws, environmental regulations, and adhere to LeMaitre’s Supplier Code of Conduct.