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Sr. Quality Engineer

Caguas, PR

The successful candidate must have experience in Quality Engineering areas for regulated environment industries such as Medical Device, Pharmaceutical, Bio-pharmaceutical or other FDA regulated industry.

Provide support and technical expertise to collaborate and support Supplier Quality Lead projects. Assist in the management of the supplier quality non conformances (send notifications, follow-up of corrective actions, management of NR on ETQ system, etc.). Analyzes quality data and identifies trends impacting risk benefits requirements of product and quality systems with primary responsibility for the maintenance of raw material suppliers. Provides recommendations or proposed changes based on data analysis. Support the revision of material specifications and or requirements. Assist on the completion of CAPA action items not limited to the review and / or identification of gaps on purchasing control procedures. Ability to effectively utilize key knowledge of business processes, analytical tools and the regulatory environment in support of the supplier quality management of purchasing controls.
Skills & Qualifications
  • Supplier Quality
  • CAPA
  • Validation
  • Medical Devices or pharmaceutical experience.
  • Bilingual (English & Spanish)
  • Bachelor Degree in Engineering field.
  • +3 years related Quality Engineering experience and FDA regulated environment. 
 Integrated Technology and Compliance Services is an Equal Opportunity Employer

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