Quality Assurance Specialist

hace 1 día


Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completo

**Company Overview**

Flexible & Integrated Technical Services, LLC is a leading provider of specialized technical services across the Island and in the US. We pride ourselves on treating our resources like family and providing top-notch quality talent to our Pharmaceutical, Medical Device, and Manufacturing industry clients.

**Job Summary**

We are seeking a highly skilled Quality System Analyst to join our team. As a Quality System Analyst, you will be responsible for monitoring and tracking quality detractors, ensuring compliance with company policies and quality standards, and developing solutions to database problems.

**Key Responsibilities**

  • Monitor and track all sources of quality detractors utilizing various systems and records.
  • Ensure compliance with company policies, procedures, and quality standards; as well as safety and environmental regulations.
  • Develop solutions to database problems of moderate scope and complexity.
  • Write and assist others in writing standard operating procedures.
  • Generate and identify significant trends, regularly reporting them to management and appropriate cross-functional teams.

**Requirements**

To be successful in this role, you will need:

  • A Bachelor's Degree in Science or Engineering.
  • At least five (5) years of previous exposure to Quality activities within the regulated industry.
  • Bilingual: Spanish and English.
  • Experience in Quality system requirements, including familiarity with US FDA 21 CFR Part 820 and ISO 13485 regulations.

**Benefits**

We offer a competitive salary and benefits package, including:

  • A flexible and family-oriented work environment.
  • Ongoing training and development opportunities.
  • The chance to work with a talented and experienced team.

**About Us**

We are a Service Provider company different from the rest. We integrate Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island and in the US. Our company is focused on our resources' well-being, while providing our clients with top-notch quality talent.



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