QA Production Engineer - Tijuana, México - North American Production Sharing

North American Production Sharing
North American Production Sharing
Empresa verificada
Tijuana, México

hace 1 semana

Rodrigo Fernández

Publicado por:

Rodrigo Fernández

Reclutador de talento para beBee
Descripción

Position Summary.
This position will assist with variety of QA related functions such as: DHR review and product release, Supplier

Control, Equipment Asset control, Internal and External Audit Program and other Quality activities


Essential Duties and Responsibilities

  • Review and compile DHR's for each lot of finished products to verify compliance with good documentation Practices, perform the final Quality release and generate COA.
  • Responsible for reviewing, approving, and releasing reports performed.
  • Manage database of the released lots and the components used on each lot to ensure traceability.
  • Reconciliation of released finished product and SCRAP quantities.
  • Ensure produced quantity of final product is aligned with customer work orders.
  • Transfer of DHR's using the electronic platform designated by customer.
  • Assign lot numbers for different manufacturing processes.
  • Oversee activities of QA production crew.
  • Assist in the coordination of QA resources for the different manufacturing processes and overtime needs.
  • Manage Supplier Control program and maintain ASL.
  • Generate Quality Agreements and Supplier Surveys.
  • Conduct Supplier Audits and generate reports.
  • Evaluate Manufacturing Deviations and support resolutions.
  • Conduct Internal audits and generate audit reports.
  • Assign, capture, and control equipment and process validation numbers as required by engineering.
  • Responsible for generating, maintaining, and controlling Asset Numbers, and facility Inventory Numbers.
  • Participates in activities related with the preparation of external audits.
  • Act as a SME for QA production processes and Supplier Control during external audits.
  • Assist in the creation of reports and charts for the Measurement of KPI's related to the quality department.
  • Be an active enforcer of good manufacturing practices inside and outside the quality department.
  • Assist in product rework activities, generating forms for the inprocess and final release inspections and controls required for quality assurance.
  • Other duties as assigned

Education and/or Experience.

  • 5 years of experience in Quality Assurance
  • Bachelor's Degree in life science or equivalent combination of education and relevant work experience.

Required Knowledge, Skills, and Abilities.

  • English level (advanced)
  • Working knowledge of QSRs & ISO 13485:201
  • Working knowledge of GMP practices
  • Strong team player.
  • Must be well organized, detailoriented, and able to maintain precise records.
  • Ability to multitask, prioritize and manage time effectively.
  • Must have strong oral and written communication skills.
  • Familiarity with root cause investigations is preferred

Tipo de puesto:
Tiempo completo


Horario:

  • Lunes a viernes
  • Turno de 10 horas

Lugar de trabajo:
Empleo presencial
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