Quality Engineer Validation (m/f/d)

Facts

  • Office: Heidelberg
  • Years of experience: 2-5
  • Schedule: full time

Job-ID

  • HE2011_001

We are looking for

  • We are looking for a Quality Engineer Validation (m/f/d) for the areas of quality management and production (m/f/d) in full-time.

Your responsibilities

  • Development, planning and implementation of qualifications and validations in production according to regulatory requirements
  • Preparation of validation master plans for process validations at the company's production sites and at contract manufacturers
  • Moderation of production risk assessments (FMEA)
  • Coordination of method validations for measurement systems
  • Qualification of measuring equipment, workplaces and test stations
  • Participation in the development of test sites
  • Participation in change and QM projects
  • Creation of QM documentation
  • Implementation of internal quality audits and supplier audits

Your qualifications

  • Completed technical studies, ideally in medical technology
  • Extensive professional experience in the tasks described above
  • Qualification as validation officer for medical devices
  • Qualifications in the field of quality management (ISO 9001 or ISO 13485, method validation, measurement equipment management, internal auditor)
  • Knowledge of (EU) MDR, FDA Quality System Regulation 21 CFR Part 820, GAMP5 and other relevant regulations would be an advantage

Your profile

  • Very good knowledge of MS-Office (Word, Excel, PowerPoint, Visio)
  • Confident knowledge of German and English (spoken and written)
  • Very good organisational skills
  • A sense of quality and responsibility and a high degree of initiative and flexibility
  • Ability to work in a team and good communication skills

We offer

  • Interesting, challenging work at a dynamic international company
  • An open business culture and a pleasant working environment
  • Modern workplaces
  • Performance-based compensation
  • A highly motivated team in an international environment
  • An attractive office in Heidelberg's Bahnstadt district, including Job ticket
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