Quality Engineer (Membrane Facility)
The Quality Engineer (Membrane Facility) at MilliporeSigma in Sheboygan Falls, WI will be part of our new, state-of-the-art membrane facility and will support the transfer of methods and processes from our Cork, Ireland facility.
The Quality Engineer will coordinate key quality initiatives for the new facility and provide overall quality assurance support for on-site manufacturing.
Daily tasks and responsibilities will include the following:
Schedule and facilitate cross-functional meetings to implement key quality system elements including, but not limited to Customer Notifications, Complaints, Deviations/CAPAs, Supplier Management, Data Integrity, Document and Record Control, Training Program, and product support functions supported by Quality SystemsSupport or facilitate customer-facing meetings to meet quality expectationsPerform risk assessmentsAid the transfer of product specifications and perform and oversee test result reviews of raw materials, in-process and final product sample inspectionsMake usage decisions Support the release, storage, distribution, returns and destruction of materialsAssist membrane pre-qualificationProvide input and support on the validation process, including review and approval of validation plans, protocols, and reportsPerform quality checks and support the data integrity programPrepare and participate in audits (customer, regulatory/certifying body)Work with Quality Control to coordinate product stability studiesWrite and review documentation to ensure compliance with company and customer quality requisitesShift/Hours:
8:
00 AM -5:
00 PM, Mon-Fri Who You Are:
Minimum
Qualifications:
Bachelor's degree in engineering, quality, chemistry, or other scientific discipline and 3
years of experience in a Quality role OR Master's degree in engineering, quality, chemistry, or other scientific discipline and 1
year of experience in a Quality role Preferred Qualifications Knowledge of ISO 9001; ISO 14001; ISO 13845; GMPsKnowledge of electronic Quality Management Systems (TrackWise, ManGo, etc.
)Ability to conduct quality investigations including root cause analysis and determine corrective and preventative actionsStrong technical skills including the ability to interpret and evaluate information submitted by technical (analytical) specialistsFamiliar with integrated and automated operations systems, e.
g.
MES (Manufacturing Execution System) Enthusiastic, flexible, and highly motivatedExcellent problem-solving skillsHighly detail-oriented and well-organizedStrong oral and written skills, including excellent presentation skillsAbility to work independently in a fast-paced, team environmentLife Science, chemical, or healthcare industry knowledge Recommended Skills Attention To Detail Auditing Chemistry Communication Iso 14000 Standard Iso 9000 Estimated Salary: $20 to $28 per hour based on qualifications.
The Quality Engineer will coordinate key quality initiatives for the new facility and provide overall quality assurance support for on-site manufacturing.
Daily tasks and responsibilities will include the following:
Schedule and facilitate cross-functional meetings to implement key quality system elements including, but not limited to Customer Notifications, Complaints, Deviations/CAPAs, Supplier Management, Data Integrity, Document and Record Control, Training Program, and product support functions supported by Quality SystemsSupport or facilitate customer-facing meetings to meet quality expectationsPerform risk assessmentsAid the transfer of product specifications and perform and oversee test result reviews of raw materials, in-process and final product sample inspectionsMake usage decisions Support the release, storage, distribution, returns and destruction of materialsAssist membrane pre-qualificationProvide input and support on the validation process, including review and approval of validation plans, protocols, and reportsPerform quality checks and support the data integrity programPrepare and participate in audits (customer, regulatory/certifying body)Work with Quality Control to coordinate product stability studiesWrite and review documentation to ensure compliance with company and customer quality requisitesShift/Hours:
8:
00 AM -5:
00 PM, Mon-Fri Who You Are:
Minimum
Qualifications:
Bachelor's degree in engineering, quality, chemistry, or other scientific discipline and 3
years of experience in a Quality role OR Master's degree in engineering, quality, chemistry, or other scientific discipline and 1
year of experience in a Quality role Preferred Qualifications Knowledge of ISO 9001; ISO 14001; ISO 13845; GMPsKnowledge of electronic Quality Management Systems (TrackWise, ManGo, etc.
)Ability to conduct quality investigations including root cause analysis and determine corrective and preventative actionsStrong technical skills including the ability to interpret and evaluate information submitted by technical (analytical) specialistsFamiliar with integrated and automated operations systems, e.
g.
MES (Manufacturing Execution System) Enthusiastic, flexible, and highly motivatedExcellent problem-solving skillsHighly detail-oriented and well-organizedStrong oral and written skills, including excellent presentation skillsAbility to work independently in a fast-paced, team environmentLife Science, chemical, or healthcare industry knowledge Recommended Skills Attention To Detail Auditing Chemistry Communication Iso 14000 Standard Iso 9000 Estimated Salary: $20 to $28 per hour based on qualifications.
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