Manufacturing Engineer

Role : Manufacturing Engineer-Urgent

Location : Mounds view, MN

need candidate from Medical domain side

Keywords : Risk assessment, Labeling , TMV,Production control, CAPA, DFMEA, PFMEA, IQ/OQ/PQ, , QSR 21 CFR 820, ISO 13485, ISO 14971, Track wise

Job Description:-

Review and approve the documents required to qualify through production process (Control Plan, Flow Charts, Process Drawings, Capability studies, Design Failure Mode Effect Analysis (DFMEA) and Process Failure Mode Effect Analysis (PFMEA)

Good experience in CAPA process.

Measurement System Analysis / Test method Validation

Test protocol and report preparation

Review and approve the documents required to qualify through production process (Control Plan, Flow Charts, Process Drawings, Capability studies, Design Failure Mode Effect Analysis (DFMEA) and Process Failure Mode Effect Analysis (PFMEA)

Good experience in CAPA process.

Measurement System Analysis / Test method Validation

Test protocol and report preparation

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.

PPAP experience

Supplier document review and approve per MDT process

Supplier control and management

Work closely with supplier

Track wise and MAP agile experience

Critical component identification and qualification

Perform receiving inspection

Driving supplier activities

Leadership toward supplier activities and interaction