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Responsible of creation, documentation of the Validation Protocols (Engineering studies, IQ, OQ, PQ).
Perform packaging simulations and validation runs and lots in the respective line/area.
Complete and processing of the validation final report (IQ, OQ, PQ).
Formulation and Execution of Engineering Test (documentation, justification, conclusion and final report).
Perform the configuration in the ERP System of each part number (Material Master, BOM and Recipe).
Support to manufacturing in the maintenance and data accuracy the information of each part number in the ERP System (Material Master, BOM and Recipe).
Perform the measurement of quality characteristics of the engineering samples, FAI and Validation samples.
Perform data analysis using statistics tool (Capability Analysis, Control Charts, hypothesis test, descriptive statistics, MSA, DOE, tec.)
Support the Manufacturing Engineer’s efforts in Product and Process Development.
Support the Manufacturing Engineer’s in the controls of products and process during post validation and lunch of process/product to manufacture.
Support to engineering complete the equipment initiation form and determine the calibration information.
Support the new equipment installation in the plant.
Responsible for the identification and storage of the engineering samples into the clean room and around to the plant.
Support the Manufacturing Engineer in the creation, release and information maintenance of the UT and OP equipment documents.
Support the Manufacturing Engineer in the creation of WI, MP, SOP, FORM and Manufacturing Standards
Encourage the manufacturing associates and supporting staff to continually drive process improvements.
Support all non-standard builds.
Contribute to improved resource efficiency by conserving energy, water, and materials where possible,
Contribute to the continual improvement of HSE systems by actively participating
Help the Manufacturing Engineer to ensure process improvements are implemented to increase product quality.
Support the Manufacturing Engineer’s work with the Quality Engineer towards identification of root causes of manufacturing issues. If a QN is issued, support the efforts to ensure the item is closed in an appropriate amount of time.
Support the Quality Engineer(s) presentation of customer complaint data and actions to the production line associates.
Performs other duties as assigned including working on the line as needed and supporting the environmental program technician by taking particulate counts and other activities.
The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.
Freudenberg Medical srl.