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Validation Quality Engineer.

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  • categoria
    costruzione
  • Contatto
    Samantha Rigoli
  • riferimento
    207665-78

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dettagli di lavoro

Are you interested in working for a global company that empowers the brands that empower the world?

We are looking for:

Validation Quality Engineer

Support the team that is dedicated to New Product introduction: participate to Design transfer meetings and provide input to DFMEA

Ensure CTQ cascade from Design input up to the inspection plan

Plan and execute or review Test Method validation (TMV).

Actively participate to Engineering Studies for process characterization: collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support

Produce reports and presentation to internal and external stakeholders

Supports and reviews validation activities for automated equipment (FAT, SAT, DQ, IQ, OQ and PQ)

Collaborates to define strategy definition for Process Validation activities

Ensures compliance with regulation by ensuring internal specification to be properly implemented

Formulates complex sampling procedures and designs special or ad hoc forms and instructions for nonstandard recording, evaluating, and reporting

Applies advanced statistical methods and performs mathematical calculations to determine manufacturing processes, staff requirements, and production standards

Performs analytical problem solving and utilizes structured decision-making skills

Are you interested in working for a global company that empowers the brands that empower the world?

We are looking for:

Validation Quality Engineer

Support the team that is dedicated to New Product introduction: participate to Design transfer meetings and provide input to DFMEA

Ensure CTQ cascade from Design input up to the inspection plan

Plan and execute or review Test Method validation (TMV).

Actively participate to Engineering Studies for process characterization: collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support

Produce reports and presentation to internal and external stakeholders

Supports and reviews validation activities for automated equipment (FAT, SAT, DQ, IQ, OQ and PQ)

Collaborates to define strategy definition for Process Validation activities

Ensures compliance with regulation by ensuring internal specification to be properly implemented

Formulates complex sampling procedures and designs special or ad hoc forms and instructions for nonstandard recording, evaluating, and reporting

Applies advanced statistical methods and performs mathematical calculations to determine manufacturing processes, staff requirements, and production standards

Performs analytical problem solving and utilizes structured decision-making skills

  • qualifiche

    • Minimum Bachelor

    • Degree in technical matter (Biomedical/Mechanical/ Automation engineering)

    • Minimum of 3 years of analogous working experience in a manufacturing environment ( Medical Device, pharmaceutical, automotive preferred) or an equivalent combination of education and experience

    • Experience in a highly regulated environment (knowledge of standards such as ISO13485, CFR 21 part 820, MDR)

    • Knowledge of Six Sigma techniques is a plus

    • MS office, Agile and Windchill is a plus

    • Fluent to communicate in Italian and English, German will be considered as a plus

    Your personal skills:

    • Strong organization skills - Rigorous & Disciplined

    • Data-Driven approach

    • Independent - Capable of working with limited supervision

    • Positive and Proactive attitude

    • Persistent & Resilient, Ability to overcome business & personal challenges

    • Strong communication skills at multiple levels of the organization

    • Creative: Ability to translate complex situations into simple solutions.

    • Plans, schedules and performs moderately complex engineering projects to evaluate, select, and adapt or modify standard manufacturing techniques, procedures, and criteria to increase the efficiency of plant operations

    • Flexible

    • Precise

    The role is based in Mezzovico and will last for 10 months.

    If you are interested in working for a global company that empowers the brands that empower the world then send us your application in English.

contattaci.

saremo felici di rispondere alle tue domande in merito a questa posizione.

SR

Samantha Rigoli

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    data di pubblicazione: 21 Marzo 2023
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