Quality Assurance Specialist

2 semanas atrás

Sete Lagoas, Minas Gerais, Brasil Stevanato Group Tempo inteiro

We are seeking a Quality Assurance Specialist to support all aspects of the Quality Management System, Product Realization, and Manufacturing Process Controls applying best practices from within the field of quality control to ensure that the materials, components, processes, and manufacturing techniques used produce high quality and reliable products.

  • The chosen candidate will define and generate quality control plans, production process controls, and procedures, working with cross-functional partners to lead and support validation activities, including statistical analysis.
  • They will execute process capabilities analysis and investigation of deviations and customer complaints, ensuring quality technical issue resolution, and engage with customers to investigate and address quality issues and define acceptance criteria/attributes.
  • Additionally, the candidate will track and report key Quality metrics, author, review, or approve technical reports evaluating trends and process/product performance data, identifying and clustering issues based on type, complexity, and time to answer, targets, etc.
  • They will also collaborate with cross-functional teams to investigate and trend deviations/OOS and customer complaints to identify CAPA to drive improvements to product quality.

About the Role

The Quality Assurance Specialist will play a key role in ensuring the compliance of the quality management system with applicable standards and requirements, supporting the definition of the required qualification and validation activities, and providing timely and accurate validation documents, including creation/review/approval of internal protocols and reports.

Qualifications

  • At least 3 years of experience in Quality Assurance/Quality Engineering/Process Engineering in manufacturing.
  • Proficiency in English is required.
  • Bachelor's of Science in Technical Field (i.e., Engineering, Material Science, Data Analytics, Statistics, etc.) or equivalent work experience.
  • Knowledge of applicable regulatory standards such as ISO 9001, ISO 13485, and GMPs.
  • Knowledge of device manufacturing Quality Management System processes and features.
  • Knowledge of technologies and control strategies for relevant manufacturing processes in a medical device and/or pharma industry.
  • Project Management and Risk Management: methodologies, techniques, tools, and applications.

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