Senior Quality Assurance Specialist

hace 5 días


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

**About Us**

Flexible & Integrated Technical Services, LLC is a unique service provider that integrates engineering, construction, maintenance, utilities, and specialized technical services across the island and in the US. We pride ourselves on treating our resources like family while delivering top-notch quality talent to clients in the Pharmaceutical, Medical Device, and Manufacturing industries.

**Job Description**

We are seeking a talented Senior Quality Assurance Specialist to join our team As a key member of our Quality Engineering team, you will be responsible for investigating manufacturing product quality and compliance issues, analyzing results, making recommendations, and developing reports. You will also optimize manufacturing processes using engineering methods such as Six Sigma and LEAN principles.

**Key Responsibilities:**

  • Investigate manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production phases prior to final product release based on engineering principles.
  • Analyze results and make recommendations for process improvements.
  • Develop routine training and documentation materials for production staff to ensure seamless knowledge transfer of project and manufacturing processes.
  • Update technical content of risk management files and documents (e.g., FMEA, QCP).

**Required Skills and Qualifications:**

To succeed in this role, you must have a Bachelor's degree in Sciences or Engineering and previous experience in Quality Engineering activities within the Medical Devices or Pharmaceutical industry. Excellent computer skills and bilingual proficiency in Spanish and English (verbal/written) are essential. Additionally, you should have experience with CAPA, investigations, and non-conformances, as well as clean rooms GDP & GMP.

**Benefits:**

We offer a flexible work environment, competitive salary, and opportunities for professional growth and development. If you are a motivated and detail-oriented individual who is passionate about delivering high-quality results, we encourage you to apply



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