- Ensure that the quality system processes required for new product transfers are established, implemented, maintainable, and manufacturable.
- Report to management on quality system performance and any needs for improvement related to new process and product transfers.
- Ensure the correct interpretation of design, process, and regulatory requirements throughout the various stages of transfer projects.
- Disseminate policies and procedures, and monitor compliance with and improvements to the quality system.
- Ensure the effectiveness of the quality system by providing direction, resources, and leadership.
- Collaborate with management staff on continuous improvement, Lean Manufacturing, or Six Sigma programs.
- Serve as lead auditor for supplier audits.




- Organize resources to provide appropriate assistance and support for all activities involving quality engineers in transfer projects.

- Advanced computing skills and proficiency in statistical software packages.
- Training in advanced-level strategic project planning.
- Advanced knowledge of risk analysis (ISO 14971).
- Ability to present information and address high-level inquiries; strong leadership and interpersonal skills.
- Over 5 years of experience in a managerial or senior-level role within Quality and/or Technology Transfer.
- Advanced English proficiency (conversational/fluent).
- Advanced knowledge of regulations: QSR (21 CFR Part 820), ISO 13485, and NOM-241.
- "LSS Black Belt" certification preferred.

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📌 Quality Manager NPI (Tijuana)
🏢 Fisher & Paykel Healthcare, S.A. De
📍 Tijuana