Quality Specialist

vor 11 Stunden

Frankfurt am Main, Hessen, Deutschland Barrington James Vollzeit 50.000 € - 80.000 € pro Jahr

The Team:

An expanding company near Frankfurt that takes on the challenge of developing, manufacturing, and distributing innovative products to support therapy at home or in clinics.

Responsibilities:

  • Creating, updating, and/or reviewing process documents and technical documentation
  • Participating in problem-solving activities related to development, production, inspection, and testing, including CAPA, NCR, and supplier-related issues
  • Participating in IQ/OQ and PQ activities, selecting test samples, validating test procedures, and risk management activities to ensure compliance with product quality standards and applicable regulations
  • Monitoring and controlling the nonconformity process
  • Organizing and managing quality control documentation
  • Supporting internal and external audits and formulating responses to audit findings and CAPAs
  • Preparing and reporting QC metrics during QMS reviews
  • Training and supporting the production and service teams regarding procedures and quality policies
  • Supporting quality management in documenting and reporting KPIs for management review
  • Planning and conducting employee training (QA training)

You Have:

  • At least two years of experience with quality control procedures for the inspection and testing of electronic components, subassemblies, and finished products, or equivalent experience
  • Practical experience in the implementation and application of statistical methods in various areas of product realization, e.g., PFMEA, DFMEA, DOE, and GR&R methods
  • Knowledge of and experience working with a quality management system (QMS) in a regulated industry
  • Experience in a medical device manufacturing environment and knowledge of ISO 13485 requirements are advantageous
  • Professional written and verbal communication skills in German and English
  • Strong presentation skills are desirable
  • Independent and efficient work style, eager to take on new responsibilities
  • Reliable team player with a proactive and independent work style and a practical approach

What is in it for you:

  • Pleasant working atmosphere in a modern, medium-sized company
  • Comprehensive onboarding support from experienced colleagues
  • A varied and exciting work environment
  • A company culture that encourages contributing ideas and initiative
  • Customer- and employee-oriented environment with flexible working hours

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