Quality Assurance Specialist

hace 4 semanas


San Juan, San Juan, Puerto Rico MG STAFFING GROUP A tiempo completo
Job Title: Quality Systems Specialist

MG STAFFING GROUP is seeking a highly skilled Quality Systems Specialist to join our team. As a key member of our organization, you will be responsible for ensuring the development and maintenance of quality programs, systems, processes, and procedures that meet regulatory requirements and industry standards.

Key Responsibilities:
  • Provide oversight for the development and maintenance of quality programs, systems, processes, and procedures.
  • Ensure compliance with policies, regulatory requirements, and industry standards.
  • Provide expertise and guidance in interpreting policies, regulatory requirements, and industry standards.
  • Work directly with operating entities to provide process analyses oversight and enforce requirements.
  • Lead audit and inspection preparation, resolution of audit and inspection findings, and liaise with auditing groups and inspectors.
  • Coordinate legal requests in support of government investigations or litigations.
  • Ensure the quality assurance programs and policies are maintained and modified regularly.
Requirements:
  • Minimum 2 years of experience working with Quality Management Systems in the regulated industry (Medical Devices).
  • Experience in Trackwise and MAP Agile tools.
  • Bachelor Degree Completed.
Preferred Qualifications:
  • Strong understanding of global regulatory requirements for medical devices, including FDA regulations (e.g., 21CFR Part 820), ISO 13485, Medical Device Directive, and European Medical Device Regulation.
  • Experience defining, driving, and implementing process improvement and functional excellence efforts.
  • Strong organizational skills and time management skills.
  • Ability to multitask, support multiple projects, function globally, prioritize, conduct team meetings, and meet project deadlines.
  • Proven experience in achieving results through influence management and motivating teams.
  • Good communication (oral and written), presentation, and interpersonal skills.
  • Ability to work in a team environment as well as independently.
  • A continuous improvement mindset.
  • Exhibits high degree of initiative and good judgment.
  • Experience working with Change Control, CAPA, documentation, audit, and/or training.


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