Quality Assurance Specialist

hace 2 semanas


San Juan, San Juan, Puerto Rico Pharmalex A tiempo completo
Quality Systems Specialist

Pharmalex is a leading consulting company for the Healthcare industry, offering professional development and a stimulating work environment. We are committed to providing exciting career opportunities in a collaborative atmosphere that values trust, respect, teamwork, creative talent, enthusiasm, and diligence.

Responsibilities:
  • Develop and maintain quality programs, systems, processes, and procedures to ensure compliance with policies and standards.
  • Provide expertise in interpreting policies, regulations, and guidelines to ensure compliance.
  • Work with operating entities to provide process analysis and oversight to enforce requirements and meet guidelines.
  • Lead audit and inspection preparation, resolution of findings, and liaison with auditing groups and inspectors.
  • Coordinate legal requests in support of government investigations or litigations.
  • Ensure quality assurance programs and policies are maintained and modified regularly.
  • Foster uniform standards worldwide and enable best practice sharing to achieve the company's mission globally.

Requirements:

  • Strong understanding of global regulatory requirements for medical devices, including FDA regulations, ISO 13485, Medical Device Directive, and European Medical Device Regulation.
  • Experience defining, driving, and implementing process improvement and functional excellence efforts.
  • Strong organizational skills, time management skills, and ability to multitask, support multiple projects, and prioritize tasks.
  • Proven experience in achieving results through influence management and motivating teams.
  • Good communication, presentation, and interpersonal skills.
  • Ability to work in a team environment and independently, with a continuous improvement mindset and high degree of initiative and good judgment.
  • Experience working with Change Control, CAPA, documentation, audit, and/or training.
  • Trackwise and MAP Agyle tools knowledge.

Education: Bachelor's degree in Science, Engineering, or related field required with a minimum of 2 years of Quality Management Systems and medical device experience.

Pharmalex is an Equal Opportunity Employer. We are committed to diversity and inclusion in the workplace.



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