We are currently seeking a Quality engineer for one of our clients in Canton of Neuchatel.
If you are looking to work in a dynamic and very friendly working environment and in the medical devices sector then this is for you.
This is an open ended temporary contract.
Please note this vacancy requires fluency in French.
Your responsibilities:
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Ensures that adequate Quality support is provided to productions and to open projects /initiatives
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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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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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Write protocols and reports for validation documentation (such as process validation, test method validation, validation plan..)
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Ensures that risk analysis activities (PFMEA) are performed and documented according to procedures and within the defined timeline
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Organize meeting for risk analysis activities and write risk management documentation
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Ensures that GMP rules are known, understood and respected on the site
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Ensure technical support to QC and laboratory department
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Escalates quality issues and makes sure that appropriate actions are in place to fix the issue in a compliant manner
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Participates and supports internal and third party audits / inspections
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Manages or participates to quality projects
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Provides support to complaint investigation if required
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Participate to procedure elaboration or update
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Ensures that CAPA are managed and documented according to plans and in compliance with procedures
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Ensures support to process improvement projects
Your profile:
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A minimum of a Bachelor Degree is required, preferable in Engineering, a Life Science or a related technical discipline.
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Experience working in a Medical Device manufacturing environment is preferred.
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Fluent in French and English
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Knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC, 21 CFR part 820
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Good communication, organizational, negotiation and interpersonal skills
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Good analytical problem-solving skills.
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Use of Agile, Oracle, EtQ, Minitab
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Use of Microsoft office tools
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Good knowledge of statistical techniques
Those lines sound interesting ? We are looking forward to receiving your application.