SUMMARY

• Engineer with the experience in a manufacturing environment blended with strong leadership and management qualification. Highly disciplined and self - motivated. Effective communicator both internationally and domestically and an energetic team player.
• Known as results oriented and have a customer-focus, get-it-done attitude. Thank you for your time and consideration.

TECHNICAL SKILLS

• Medical Device, Military products, Electronic ISO 9001, 13485, 14971, QSR 21 CFR 820
• Confidential, FMEA, Control Plan, Fix documents Health & Hazard Evaluation, Risk Assessment
• Design & Clinical Risk Management (DCRM) Risk Management Process, Procedure
• MRB team member, Disposition of product PFMEA, PRM, SOP and Procedure
• Continuous Improvement, Documentation Daily support of manufacturing operations
• QRQC (Quick Response Quality Control) Customer Complaints evaluation and review
• Create/update SOP/W.I. & procedures Document Change Order (DCO)
• Document Control, Validation, Verification Engineering Change notice (ECN), E.C. Orders (ECO)
• 8D (8-Step Corrective Actions Report) Review non-conforming materials - Patience Complaints
• Good Documentation Practices (GDP) Determine proper corrective/preventative action
• Good Manufacturing Practices (cGMP) International and domestic supplier and internal audit
• Root cause investigation, CAR, SCAR Assembly line, manufacturing operationMilitary Standard MIL-883, MIL-PRF38535 Review Customer and Supplier Document
• Lean Manufacturing, Kaizen, 5S, 5Why Support Incoming, In-Process & Outgoing Inspection

PROFESSIONAL EXPERIENCE

Quality Engineer

Confidential - Walkersville, MD

Responsibilities:

• Create a checklist for seven legacy products Confidential and Gap Assessment to review and determine what document needed to complete the products Confidential
• Performed gap analysis to identify incomplete or missing information required for a complete Confidential folder.
• Created Confidential checklist include Design Input/Output/Verification/Validation/Review/Change/Transfer required for Confidential folder.
• Performed gap analysis to identify incomplete or missing information required for a complete 510(k) submission.
• Evaluate and review files to comply with applicable standards, regulations, and FDA guidance.

Quality Engineer

Confidential - Bothell, WA

Responsibilities:

• Review and investigate and verify closed Confidential for FDA audit. Each product needs to have a gap analysis to determine obsolescence or validate.
• Reviews checklist to verify all requirement meet the Confidential applicable standards and specification.
• Assist Confidential Owners with the verification, and documentation of Corrective and Preventive Actions to ensure completeness.
• Follow up with owner on all action items until items are effectively completed and closed.
• Support and ensure that corrective and preventive actions are issued as required, properly investigated, documented, effective, and completed.
• Review, revised and improved Problem description, Communication Summary, Risk Summary, Containment Action, Root Cause, CA, PA, Effectiveness Criteria, Implementation Summary, Reinvestigation Notes, Closure Comment, and post closure for Confidential .
• Conduct product and process Corrective and Preventive Action ( Confidential ) investigations from issue identification through implementation of solution and effectiveness monitoring.
• Document all phases of Confidential activity in compliance with applicable standards including 21 CFR part 820.100 and ISO 13485, and procedural requirements.
• Maintain Confidential records, keeping them in a state of audit readiness.

Quality Engineer Design Quality Engineer

Confidential

Responsibilities:

• Design Quality Engineer project team member, support Technical File remediation for Medical Device Directive (MDD; EU Council Directive 93/42/EEC) and for CE-Marking.
• Supports sustaining engineering on Technical file remediation and review and verified file requirements (e.g. Essential Requirements, Risk analysis, design control, clinical evaluation, test reports, manufacturing, and sterilization) and all supporting information and detail documentation.
• Review and support risk management to ensure high level of compliance to FDA QSR 21 CFR 820, ISO 13485 and ISO 14971and European standard in all assigned areas.
• Provide inputin support of design control activities. Reviewed documents associated with the design and manufacture of products including specifications, testing protocols and reports.
• Support Design Verification activities (e.g. Design Review, Tolerance Stack, and Mechanical Testing).
• Review and approveverification/validation test protocols and reports documentation, Risk Management Report (RMR), Risk Management Plane (RMP), Design & Clinical Risk Management (DCRM/FMEA), Essential Requirements Checklist (ERC), List of Applied Standards (LoAS), functional assessment (FA), Corrosion Resistance Rational, External Part List (EPL), and Risk Management (RM).
• Verified and support and assist the team to ensure all standards and documentation reference in the SEV (Standard Evaluation) evidence are accurate.
• Review and verified all Surgical Technique Guide (STG) precaution, warning, Article lists that references in the documentation for technical file.
• Review, verification and approval of Sales and Complaints (S&C), product article list to ensure all parts in scope are analyzed over the correct time period.
• Ensure in Risk Management Report (RMR) all AFAP (As Far As Possible)/High risks are adequately addressed from the DCRM and Production Risk Management (PRM/PFMEA) documents.
• Project Team member for remediation of supplier Process FMEA (PFMEA) and company internal Production Risk Management (PRM) to ensure compliance to FDA QSR 21 CFR 820, ISO 13485 and ISO 14971.
• Interface with Product Development engineer (PDE), Manufacturer engineer (ME) and different team member to discuss the design output, hazards and hazard situation and cause of manufacturing failure to complete the remediation of Supplier manufacturing process flow (PFMEA).
• Reviewed supplier PFMEA and transfer the information to company created Production Risk Management (PRM) / Process Failure Mode Effects Analysis (PFMEA) per stablish company risk management documentation and procedure.
• Reviewed supplier manufacturing process flow/traveler/router and worked with suppliers on all quality related issues. Such as hazards and hazard situation, cause of manufacturing failure, current control controls and reference for control to complete the Production Risk Management (PRM)/Process FMEA.
• Review sales and complaints investigation data to determine and understand the nature of the complaint and determine the complaint is valid or invalid.
• Understand and work with drawings, prints, Inspection Sheet, manufacturing assembly part router, traveler, Packaging, Shipping and Supplier PFMEA/Router of parts.