Quality Engineer Resume Warsaw, IN - Hire IT People

SUMMARY

Experienced Medical Device Engineer with strong problem solving skills.
Product Development / Product Sustenance experience with focus on Quality Engineering.
Implemented DHF Remediation for Medical Device Manufacturers.
Experienced in V & V (Verification/Validation).
Expertise in CAPA (Corrective Action Preventive Action) with TrackWise validation for managing CAPA actions.
Implemented CAPA/Field Action Reviews, supported product recall.
Created and evaluated existing DFMEA and PFMEA to determine if complaint issues and risk are identified and required risk assessments are updated.
Implemented Risk Management Procedures as per ISO 14971 Regulations.
Skilled in problem solving techniques involving Lean/Six Sigma statistical tools such as Minitab
Skilled in using Lean Management Tools: Kaizen, 6S, Kanban.
Experience in SolidWorks, Pro - E.

TECHNICAL SKILLS

FMEA
Validation plan
Audit Trails
PFMEA
System procedures
CSV
GAP Analysis
Six Sigma
5S
Root Cause Analysis
Doors
GD&T
Product Design & Analysis SolidWorks
CREO 5.0
Pro-E
CATIA V5
ANSYS
AutoCAD

PROFESSIONAL EXPERIENCE

Quality Engineer

Confidential, Warsaw, IN

Responsibilities:

Quality Engineering /Manufacturing Quality Systems/Process Multiple Remediation Projects.
IQ, OQ, PQ, Protocol Approval, Development and Execution, performed customer complaints analysis on (ETQ) NCR Product Release Approvals, CAPA, QS Auditing, internal customer interviews, heavy interaction with multiple business groups for Supplier Chain Management. Customer Complaints Investigation.
Worked CAPA/Complaints in ETQ
Conducted proactive Remediation of CAPA Processes and Systems to advance QSIP on goingContinuous Process Improvement.
Review NCMR and CAPA designed and deployed systems for complaint handling and resolutions.
SDLC Product review, access, approve for use.
Customer Complaints review and resolution. Investigate, CAPA's, determine root cause, and design corrective and preventive action.
Support Manufacturing by performing remediation failure investigation, process improvement, and Processing NCMRs, Participate in validation writing of protocol activities by reviewing protocols and executing activities where necessary.
Updating manufacturing and quality instructions to current standards. Authored Test Method Validations (TMV's) for catheter manufacturing and inspection processes.
Performed IQ, OQ, PQ sustaining engineering protocols.
Complaint processing duties for investigation and root cause determination. Supervised, Receiving Inspection, Post Sterile Laboratory, Final Product Release Approval. ETQ, NCR and ETQ CAPA applications trained.
Batch records review and approval for release.Multiple NCR's, Customer Complaints, Sustaining Engineering Duties.
Assigned as a Lead Quality Systems Auditor. Track wise complaint/NCR processing.
Approved Final DHR Release records. Ethylene Oxide Sterilization, GAMMA, Etc.
Worked on CAPA remediation and special remediation projects.
Apply FDA regulations (21CFR82O) and ISO standards to manufacturing environment, audit quality systems, processes and products and communicate required action to TEMPeffectively correct findings as expected.
Review of DHF, DHR, DMR, Design and Development, Validation and Verification of Technical File, for Regulatory and Product safety compliance

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Quality Engineer Resume

Warsaw, IN

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