Quality Assurance Engineer

hace 2 semanas


Tijuana, Baja California, México Michael Page International México Reclutamiento Especializado S.A. de C.V A tiempo completo

Job Description:

We are seeking a highly skilled Sustaining Quality Engineer to join our team at Michael Page International México Reclutamiento Especializado S.A. de C.V.

About the Role:

This is an exciting opportunity for a talented Quality Engineer to take on a challenging role in sustaining existing medical devices.

  • Responsibilities include ensuring quality and regulatory compliance of existing products in the medical industry, investigating and resolving quality issues for released products, managing Non-Conformance Reports (NCR) and leading Corrective and Preventive Actions (CAPA).
  • Lead process validations, including IQ, OQ, and PQ, for sustaining products and ensure compliance with regulatory standards (FDA, ISO 13485, etc.).
  • Manage product documentation updates (DHF, DMR, etc.) and handle Change Control processes (ECOs). Collaborate with suppliers and customers to resolve quality-related issues.

Requirements:

  • Bachelor's degree in Engineering, Quality, or related field.
  • 3+ years of experience in quality engineering and sustaining.
  • Proven experience in the medical device industry, particularly in high-volume, high-paced manufacturing environments.
  • Strong knowledge of regulatory requirements (FDA, ISO 13485, PMDA, MDR, etc.) and quality management systems (QMS).
  • Experience with root cause analysis, CAPA, NCR, and process validations, as well as proficiency in statistical analysis tools (SPC, Minitab, etc.).
  • Excellent problem-solving and communication skills, with a hands-on, proactive approach.
  • Advanced English proficiency.


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