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Integra LifeSciences QS Senior Engineer in CH, Switzerland

Changing lives. Building Careers.

Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.

Responsibilities:

QMS:

  • Participate to procedure creation and update

  • Participate to document control activities

  • Ensures GMP, GDP rules are known, understood and respected in the site

  • Ensure Quality System support in all departments

  • Escalates quality issues and make sure that appropriate actions are in place to fix the issue in a compliant manner.

  • Manages or participates to quality projects

CAPA:

  • Act as CAPA trainer for the site

  • Act as CAPA Process Owner

  • Ensure CAPAs are managed in compliance with internal procedures as well as applicable standards

  • Follow up CAPA process and ensure CAPA are handled and documented adequately in a timely manner

AUDIT:

  • Act as Audit process trainer

  • Participates and supports internal and third party audits / inspections

  • Perform internal audits

  • Ensure internal Audit planning is implemented and follow up

  • Ensure Audit process support to all departments

QUALITY PLAN:

  • Act as QP process trainer

  • Ensure QP are managed in compliance with internal procedures as well as applicable standards

  • Participates and supports the QP process

  • Ensure QP process is implemented and follow up

KPI, Quality Reviews

  • Ensure KPI and Quality Reviews are handled in compliance with internal procedures as well as applicable standards

  • Participates and supports the KPI, Quality Review process

Qualification :

  • A minimum of a Master’s Degree is required, preferable in Engineering, a Life Science, pharmaceutical or a related technical discipline.

  • Minimum Experience of 5 years working in a Medical Device, or pharmaceutical or technical manufacturing environment is preferred. 

  • Fluent in French and English

  • Knowledge of Medical device standards and regulations such as ISO13485, EUMDR 2017/745, 21 CFR part 820

  • Good communication, organizational, negotiation and interpersonal skills

  • Good analytical problem-solving skills. 

  • Use of Agile, Oracle, EtQ, TWD, ICDH

  • Use of Microsoft office tools

  • Good knowledge of statistical techniques

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