Quality Assurance Specialist

3 semanas atrás

Sete Lagoas, Minas Gerais, Brasil Stevanato Group Tempo inteiro
Job Title: Quality Specialist

We are seeking a highly skilled Quality Specialist to join our team at Stevanato Group. The successful candidate will be responsible for supporting all aspects of the Quality Management System, Product Realization, and Manufacturing Process Controls.

Key Responsibilities:
  • Define and generate quality control plans, production process controls, and procedures.
  • Lead and support validation activities, including statistical analysis.
  • Execute process capabilities analysis and investigation of deviations and customer complaints.
  • Engage with customers to investigate and address quality issues and define acceptance criteria/attributes.
  • Track and report key Quality metrics.
  • Author, review, or approve technical reports evaluating trends and process/product performance data.
  • Collaborate with cross-functional teams to investigate and trend deviations/OOS and customer complaints to identify CAPA to drive improvements to product quality.
  • Locally deploy global quality and technical specifications for products and services in cooperation with internal stakeholders.
  • Verify customer product specifications align with site capabilities to support customer quality expectations and implement efficient tools in handling SG and customer specifications compliant to applicable regulations.
  • Participate in carrying out new projects ensuring technical assistance and validation.
Requirements:
  • 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.
  • Proficient in metrology and calibration techniques.
  • Working knowledge of statistical methods used in manufacturing.
  • Proficient in Geometric Dimensioning and Tolerancing (ANSI Y-14.5).
  • Skills: Problem Solving, Project Management, and Strong Technical Writing.
  • Risk-Based Thinking Approach.
About Us:

We are a dynamic organization with great customers and a culture where people are valued and empowered to deliver amazing results. We are also growing and looking to hire talented and passionate individuals to join our team.

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