Quality Assurance Specialist

hace 4 semanas


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

Job Summary

Flexible & Integrated Technical Services, LLC is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring compliance with policies and performance standards in the Manufacturing area. This role requires a strong understanding of global regulatory requirements for medical devices, including FDA regulations, ISO 13485, and Medical Device Directive.

Key Responsibilities

Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures.
Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance.
Works directly with operating entities to provide process analysis oversight continuing to enforce requirements and meet guidelines.
Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
Coordinates legal requests in support of government investigations or litigations.
Ensures the quality assurance programs and policies are maintained and modified regularly.

Requirements

Bachelor's Degree in Engineering or Science and two (2) years of exposure within the Pharmaceutical & Medical Devices Industry.
Bilingual: Spanish and English
Soft Skills: Organization and Time Management Skills.
Shift: 1st Shift.
Experience in: Trackwise, and MAP Agyle tools, Change Control, CAPA, and documentation, FDA, GMP, ISO 13485, and GMP Regulations.

About Us

We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you. We integrate Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island (and in the US as well). Our company is flexible, family-oriented, and focused on our resources' well-being while providing our Pharmaceutical, Medical Device, and Manufacturing industry clients with top-notch quality talent.



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