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Senior Quality Assurance Specialist for Medical Devices

vor 2 Monaten


Olten, Solothurn, Schweiz Gerresheimer Vollzeit

Job Description

At Gerresheimer, we seek a dedicated Senior Quality Assurance Specialist for Medical Devices to join our team.

As a key member, you will be responsible for ensuring the conformity of our products and product documentation throughout the entire product life cycle, with a focus on development and industrialization, Design Control.

Key Responsibilities:

  • Collaborate in the development of complex (electronic, software, and mechanic) medical devices.
  • Develop and ensure compliance with quality requirements for drug delivery systems and medical devices in development projects.
  • Review and approve changes to product design and manufacturing processes.
  • Serve as the primary contact for customers and suppliers regarding product quality, including measures such as NC, CAPA, SCAR, etc.
  • Collaborate in the equipment qualification and process validation of external production partners.
  • Provide expert guidance on quality-related questions in the context of audits by customers or authorities.

Requirements:

  • Completed technical or scientific education or equivalent.
  • Several years of experience in working in the field of medical technology products, pharmaceuticals, and/or in-vitro diagnostics.
  • Practical experience in the risk management method for medical devices.
  • Knowledge of the interpretation and implementation of regulatory requirements for medical devices (MDR, EN ISO 14971, 21 CFR 820, EN 13485).
  • Strong problem-solving and communication skills, with ability to work in a structured and result-oriented manner.
  • Proficient in German (B2) and English (C1).

What We Offer:

  • Opportunity to work in a dynamic team.
  • Professional development and growth opportunities.
  • A motivating and performance-oriented work environment.
  • A competitive salary and benefits package.
  • Support for ongoing education and training.