Quality Assurance Specialist R&D and Global Engineering

Vor 3 Tagen

St Gallen, Sankt Gallen, Schweiz SCHOTT Vollzeit

About SCHOTT

We are a leading manufacturer of pharmaceutical primary packaging and analytical lab services. Our Business Unit Pharmaceutical Systems operates in 13 countries worldwide, producing over 10 billion syringes, vials, ampoules, cartridges, and special articles of tubing glass or polymer.

Your Role

  • You will be responsible for maintaining and developing the R&D Quality Management System (QMS) and ensuring compliance with ISO 15378 and ISO 13485.
  • You will manage the R&D Corrective Action Preventive Action (CAPA) process and perform internal audits.
  • You will drive continuous improvement within R&D and its interfaces.
  • You will ensure compliant harmonized development documentation.
  • You will provide guidance and training to your colleagues to ensure they are easily compliant with our QMS.

Your Profile

  • You hold a University degree in Engineering, Life Science, or a similar field.
  • You have 3+ years of working experience in the pharmaceutical packaging-, medical device-, or pharma industry with development environment and contact to QMS.
  • You possess diligence, proactive, and structured independent working skills.
  • You have knowledge in QMS and document management, as well as Good Document Practices (GDocP).
  • You have strong presentation and moderation skills and a drive to accuracy.
  • You have experience in audits, preferably ISO 13485 / ISO 15378.
  • You have excellent interpersonal and communication skills and enjoy exchanging with internal and external stakeholders.

Your Benefits

SCHOTT offers a unique corporate culture where everyone has the opportunity to develop their entire potential. We emphasize equity, diversity, and inclusion. You can expect interesting tasks, challenging projects, and motivated and friendly teams in fields that influence our future.

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