QA Engineer

hace 2 semanas

Tijuana, México North American Production Sharing de México S.A. de C.V. A tiempo completo

International diagnostic and medical device company is looking for

**QA Engineer**

As a Quality Engineer, you will manage and lead operations and continuous improvements of the company’s CAPAs and Supplier Management programs to ensure the best practices and compliance with federal and global regulatory requirements

**Essential Duties and Responsibilities**

  • Manage the company’s CAPA process with focus on driving improvements in products and process performance.
  • Coordinates and support activities for root cause investigations, and implementation of corrections and corrective actions, as well as evaluation of effectiveness of implemented changes.
  • Facilitate cross functional team discussions in support of CAPA investigations and risk impact assessment report documents as per defined timelines Monitor CAPA KPIs, perform analysis, and interpret trends for process/product quality improvements.
  • Provide training and coaching to employees authoring, reviewing, and approving CAPAs.
  • Establish and maintain expert knowledge on quality system CAPA regulatory requirements in accordance with applicable FDA Regulations (21 CFR: Parts 820), and ICH Guidance, as well as other applicable regulatory requirements applicable to the organization.
  • Responsible for managing the day-to-day activities of the Approved Supplier List. This includes review and approval of all new suppliers or changes to existing suppliers.
  • Qualify, manage, and monitor supplier performance per supplier management approved processes. Identify gaps in current processes to develop, define, establish, and document new processes, as needed.
  • Monitor and ensure that required certifications, paper audits or site audits coming due for renewal are completed on time.
  • Assuring all associated documentation is obtained, such as, Quality Agreements, Surveys, Quality System certifications.
  • Collaborates with internal teams and suppliers to create new or modify existing Quality Agreements.
  • Supplier Program

**Requirements**

  • BA/BS or equivalent in life science or engineering, or equivalent focus of study from an accredited university or college with 5-8 years relevant experience or typically 3-5 years with a Master’s degree in related field.
  • Proficient knowledge of Quality Engineering policies, principles and best practices including quality standards: ISO 13485, 21CFR Part 820, ISO 14971, and other appropriate industry standards.
  • Strong team player;
  • Must be well organized, detail-oriented and able to maintain precise records;
  • Ability to multi-task, prioritize and manage time effectively, while maintaining quality.
  • MS Office (Word, Excel, PowerPoint, MS Project)
  • Must have strong oral and written communication skills and computer skills.
  • English fluency (Must)

Tipo de puesto: Tiempo completo

Horario

  • Diurno

Lugar de trabajo: Empleo presencial

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