Company:
Katalyst Healthcares & Life Sciences
Location: Mounds View
Closing Date: 26/11/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
Responsibilities:
Ensure that suppliers deliver quality parts, materials, and services.
Qualify suppliers according to company standards.
Review and approve the documents required to qualify through PPAP process (Control Plan, Flow Charts, Process Drawings, Capability studies, Design Failure Mode Effect Analysis (DFMEA) and Process Failure Mode Effect Analysis (PFMEA).
Supplier risk segmentation.
Supplier Quality Agreements.
Supplier coordination in support of selection and qualification of new suppliers or changes to existing supplied products and processes.
Support, review, and approval of Process Validation (IQ/OQ/PQ), MSA and Control Plan.
Route PPAP Checklist in Agile.
Leverage GMP (Good Manufacturing Practices). Navigates the complexities of various industry regulations to include FDA Quality System Regulation (QSR 21 CFR 820), ISO 13485, and ISO 14971.
Requirements:
Measurement System Analysis / Test method Validation.
PPAP experience.
Supplier document review and approve per MDT process.
Supplier control and management.
Work closely with supplier.
Mini tap experience.
Critical component identification and qualification.
Perform receiving inspection.
Driving supplier activities.
Leadership toward supplier activities and interaction.
Ensure that suppliers deliver quality parts, materials, and services.
Qualify suppliers according to company standards.
Review and approve the documents required to qualify through PPAP process (Control Plan, Flow Charts, Process Drawings, Capability studies, Design Failure Mode Effect Analysis (DFMEA) and Process Failure Mode Effect Analysis (PFMEA).
Supplier risk segmentation.
Supplier Quality Agreements.
Supplier coordination in support of selection and qualification of new suppliers or changes to existing supplied products and processes.
Support, review, and approval of Process Validation (IQ/OQ/PQ), MSA and Control Plan.
Route PPAP Checklist in Agile.
Leverage GMP (Good Manufacturing Practices). Navigates the complexities of various industry regulations to include FDA Quality System Regulation (QSR 21 CFR 820), ISO 13485, and ISO 14971.
Requirements:
Measurement System Analysis / Test method Validation.
PPAP experience.
Supplier document review and approve per MDT process.
Supplier control and management.
Work closely with supplier.
Mini tap experience.
Critical component identification and qualification.
Perform receiving inspection.
Driving supplier activities.
Leadership toward supplier activities and interaction.
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