Sr. Quality Manager

Location: Alamar

Responsibilities:

• Focus on customer quality inquiries
• Attend in a timely manner all customer feedback, and prepare the site for customer visits and audits.
• Plan with appropriate agencies all applicable regulation audits, including follow-up, CAPA, closure of any nonconformance, and issue of appropriate reports
• Oversee product or process holds, and product recalls as needed
• Initiate, lead, and supervise Corrective actions, CAPA response in a timely manner, always meeting the time frame required by the customer and/or internal procedures
• Ensure the correct identification of product status, including nonconformance product segregation and identification through all the process steps.
• Ensure process and product compliance with GMP and applicable regulatory requirements.
• Lead or participate in teamwork efforts to deploy and implement quality and process analysis tools or systems such as PFMEA, control plan, PDCA, RCA, SPC, DOE, CPk, etc.
• Participate in change management by following up on and approving product and process changes
• Collaborate in general Continuous improvement activities
• Issue a monthly report of overall quality performance and status in relation to customer feedback, customer complaints, internal process non-conformities, CAPA status, etc.

Minimum Requirements:

• Ingeniería Industrial, Manufactura, Procesos, o carrera afín
• Más de 5 años de experiencia en puesto similar
• Experiencia en industria médica y automotriz
• Auditor Líder ISO 9000, ISO 13485
• Mejora continua
• Resolución de problemas
• SPC
• Conocimiento en IATF 16949
• IQ, OQ, PQ Validations, CFR 820, y FDA
• PPAP, AIAG CORE TOOLS
• Certificación ASQ QE
• Green belt o Black belt
• Inglés avanzado
• Visa es un plus

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