HC Quality Support Center Specialist

hace 1 mes

Cali, Valle del Cauca, Colombia UPS A tiempo completo

Job Title: HC Quality Support Center

Job Summary:

The HC Quality Support Center is seeking a highly skilled and experienced Quality Assurance Supervisor to oversee the performance and activities within the Quality Support Center. The successful candidate will be responsible for communicating the quality policy and objectives, implementing and maintaining quality systems, and ensuring compliance with regulatory requirements.

Key Responsibilities:

  • Develop and manage quality records, including validation, supplier management, and training, in alignment with the quality policy and processes.
  • Manage and execute the Quality System Training Program.
  • Manage validation documents, determine applicable regulations, and review and approve testing of changes to validated systems.
  • Manage reviews of policies, procedures, regulations, and specific work instructions.
  • Develop a set of criteria for trending of quality data for their area of responsibility to assist with performance trending.
  • Participate in regular internal and external meetings and management reviews for the area of responsibility.
  • Provide training, support, and developmental opportunities to direct reports.
  • Manage resources and people processes to ensure the day-to-day administration of processes and formal procedures.
  • Provide direction and coordination to the team and coordinate regular training(s) related to change controls and risk management.

Preferred Competencies:

  • Knowledge of different country regulations and ISO 9001/ISO 13485 standards.
  • Advanced English language skills.
  • Strong project management skills.
  • Strong analytical and people management skills.
  • Good knowledge of a Quality Management System and electronic Management System (eQMS).
  • Good knowledge of Microsoft Office (Excel, Word, Outlook, Access).
  • Ability to create networks and collaborate with various internal and external stakeholders.
  • Ability to prioritize decisions which may have a significant risk for the company.
  • Identify potential gaps in the processes and make recommendations for possible improvements.
  • Strong time management skill, able to work within time-limits (deadlines).

Minimum Qualifications:

  • Bachelor's Degree (or internationally comparable degree) – Preferred.
  • Bachelor's Degree (or internationally comparable degree) – Science or related discipline – Preferred.
  • A minimum of 3 years' experience in the healthcare industry in a Quality role.

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