Quality Assurance Complaints Associate — Hybrid/Remote

Alcon; Aguascalientes; Ibrido; MXN 240.000 - 360.000; Tempo pieno

Vantaggi offerti da questo lavoro

Flexible hours

Remote work possibilities

Descrizione del lavoro

Alcon in Mexico City is seeking an Associate Complaints to join the Quality & Regulatory Affairs team. You will process and investigate product complaints, ensure regulatory documentation, and support continuous improvement in quality systems.

The role emphasizes collaboration with cross-functional teams, an eye for detail, and adherence to GxP regulations. Fluency in English and Spanish is required, with hybrid work options available.

Competenze

• Education: Bachelor’s degree (scientific, pharmacy, or healthcare-related).
• 6 months of experience in Quality Assurance, Pharmacovigilance, Technovigilance, or Complaint Handling within medical device and/or pharmaceutical industry desirable.
• Knowledge of pharmacovigilance and technovigilance regulations, complaint handling processes, and Quality Management Systems (e.g., ISO 13485) desirable.
• Fluency in English and Spanish.
• Strong analytical, organizational, and communication skills.
• Computer literacy with standard software platforms.
• Ability to manage priorities, work independently, and collaborate effectively with cross‑functional and multicultural teams.

Mansioni

• Apply specialized knowledge to complete tasks and achieve objectives in the Complaints discipline.
• Serve as the primary contact to process, investigate, and monitor trending and reporting of product defect complaints, addressing and expediting them in alignment with company policy and procedures.
• Collaborating with Medical Safety and Research and Development teams on adverse events.
• Ensure compliance with regulatory agencies' reporting requirements and adhere to Good Practice (GxP) regulations by strictly following Standard Operating Procedures.
• Support complaint activity monitoring, provide suggestions to modify existing manufacturing or packaging processes, and maintain unified product defect investigation operating procedures.
• Collaborate with cross‑functional teams to drive problem-solving and innovation using scientific principles.
• Maintain accurate and complete documentation, ensure rigorous quality control, and complete all required training to meet individual job requirements.
• Contribute to the overall compliance of the organization and support continuous improvement.

Conoscenze

Quality Assurance

Pharmacovigilance

Technovigilance

Complaint Handling

Bilingual English/Spanish

Formazione

Bachelor’s degree in Science/Healthcare

Descrizione del lavoro

Alcon in Mexico City is seeking an Associate Complaints to join the Quality & Regulatory Affairs team. You will process and investigate product complaints, ensure regulatory documentation, and support continuous improvement in quality systems.

The role emphasizes collaboration with cross-functional teams, an eye for detail, and adherence to GxP regulations. Fluency in English and Spanish is required, with hybrid work options available.