Senior Sterilization Operations Manager

hace 4 semanas


Tijuana, Baja California, México Corza Medical A tiempo completo
Role Overview

We are seeking a highly skilled Senior Sterilization Operations Manager to spearhead our sterilization strategy for the wound closure organization. This critical role ensures that all cleanroom and controlled environment rooms meet regulatory standards and daily practices support a relevant monitoring cadence.

Key Responsibilities
  • Develop and execute sterilization strategies to ensure Corza products continue to meet functionality, design standards, and regulatory requirements.
  • Lead sterilization and product release after sterilization activities, ensuring seamless coordination with R&D, Quality Engineering, and other departments.
  • Manage all sterilization deviations, identifying root causes and implementing corrective actions to prevent recurrence.
  • Collaborate with cross-functional teams on new product introductions, sustaining product changes, product transfers, and change control management to ensure sterile products meet intended use requirements.
  • Ensure cleanroom and/or controlled environment room validations and controls adhere to relevant standards and are appropriate for the product being manufactured.
  • Oversee studies and analysis related to bioburden, cytotoxicity, pyrogenic, or other sterile-barrier activities.
Requirements and Qualifications
  • Bachelor's degree in Engineering, Chemistry, or Microbiology.
  • At least 3+ years of experience working in a Sterilization engineering role for medical devices.
  • Strong knowledge of quality management systems as they pertain to sterilization and microbiology requirements.
  • Experience with CAPAs handling, Non-conformance, Deviations, Complaints handling (Product Evaluations Reports, Notifications to Competent Authorities)
  • Knowledge of statistical analysis tools and their use in product design and manufacturing.
  • Six Sigma training is a plus.
  • Experience in working with Gamma and EtO sterilization.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Fluent in Spanish and English required.
Estimated Salary Range: $120,000 - $150,000 per year

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