Senior Quality System engineer

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p>Participate to procedure creation and update

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

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p>Ensure Quality System support to all departments

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p>Escalates quality issues and makes sure that appropriate actions are in place to fix the issue in a

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p>compliant manner.

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p>Manages or participates to quality projects 

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p>CAPA:

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p>Act as CAPA Process Owner

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

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p>Follow up CAPA process and ensure CAPA are handled and documented adequately

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p>Ensure Audit process support to all departments 

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p>AUDIT:

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p>Participates and supports internal and third party audits / inspections

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p>Perform internal audits

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p>Ensure internal Audit planning is implemented and follow up

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p>Ensure Audit process support to all departments 

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p>QUALITY PLAN:

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

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p>Participates and supports the QP process

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p>Ensure QP process is implemented and follow up

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p>KPI, QMR

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p>Ensure KPI and QMR are handled in compliance with internal procedures as well as applicable

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p>standards

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p>Participates and supports the KPI, QMR process

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p>Ensure QP process is implemented and follow up 

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p>Your profile:

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p>A minimum of a Bachelor Degree is required, preferable in Engineering, a Life Science or a related technical discipline.

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p>Minimum Experience of 5 years working in a Medical Device manufacturing environment is preferred.

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p>Fluent in French and English

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p>Knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC, EUMDR 2017/47, 21 CFR part 820

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p>Good communication, organizational, negotiation and interpersonal skills

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p>Good analytical problem-solving skills.

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p>Use of Agile, Oracle, EtQ, TWD

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p>Use of Microsoft office tools

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p>Good knowledge of statistical techniques

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p>Those lines sound interesting ? We are looking forward to receiving your application.