Senior Quality Assurance Strategic Lead

hace 4 días


Tijuana, Baja California, México Fine Talent A tiempo completo
Job Overview

Fine Talent is seeking a Senior Quality Assurance Strategic Lead to oversee quality and regulatory compliance for multisite manufacturing operations in Mexico.

Responsibilities
  • Provide visionary leadership to quality assurance teams across multiple sites, fostering a culture of accountability, innovation, and excellence.
  • Develop and execute a strategic roadmap for quality assurance that aligns with the company's global objectives and regulatory standards.
  • Serve as the primary quality representative to senior leadership and external stakeholders, including regulatory bodies and customers.
Quality Management Systems (QMS)
  • Lead the implementation, harmonization, and continual improvement of ISO 13485-certified QMS across all manufacturing sites.
  • Establish standardized processes, policies, and metrics to ensure consistency and compliance across operations.
  • Drive audit readiness and lead internal and external audits, including FDA, ISO, and other regulatory inspections.
Regulatory Compliance & Risk Management
  • Ensure full compliance with global regulatory requirements, including FDA 21 CFR Part 820, EU MDR, and applicable regional standards.
  • Develop and manage a robust risk management framework, including Risk Analysis, Failure Mode and Effects Analysis (FMEA), and mitigation plans.
  • Act as the primary point of contact for regulatory agencies, managing interactions, submissions, and inspection follow-ups.
Required Qualifications
  • Bachelor's degree in engineering, Quality Management, or a related field (Master's or advanced degree preferred).
  • A minimum of 12 years of progressive experience in quality assurance, with at least 5 years in a director or senior leadership role in the medical device industry.
  • Extensive knowledge of ISO 13485, FDA regulations (21 CFR Part 820), EU MDR, and other relevant global regulatory standards.
  • Certifications such as CQE, CQA, or Six Sigma Black Belt are highly desirable.

We offer a competitive executive compensation package of $150,000 per year, along with opportunities for professional growth and development in a dynamic, innovative environment.



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