Quality Engineer

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p>Ensures that adequate Quality support is provided to productions and to open projects /initiatives

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p>Ensures that Non Conformances are initiated, dispositioned, approved and investigated according to plans and in compliance with procedures and regulatory requirements

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p>Ensures that quality activities for validation of new processes/ products are performed and documented according to procedures and within the defined timeline

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p>Write protocols and reports for validation documentation (such as process validation, test method validation, validation plan..)

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p>Ensures that risk analysis activities (PFMEA) are performed and documented according to procedures and within the defined timeline

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p>Organize meeting for risk analysis activities and write risk management documentation

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p>Ensures that GMP rules are known, understood and respected on the site

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p>Ensure technical support to QC and laboratory department

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

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

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p>Manages or participates to quality projects

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p>Provides support to complaint investigation if required

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p>Participate to procedure elaboration or update

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p>Ensures that CAPA are managed and documented according to plans and in compliance with procedures

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p>Ensures support to process improvement projects 

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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>Experience 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, 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, Minitab

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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> 

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

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