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 (Centro-Norte)
🏢 Fisher & Paykel Healthcare, S.A. De
📍 Centro-Norte