SUMMARY:

• Six Sigma Green Belt Certified Engineering profession in medical device manufacturing with wide range of experience in Design, Manufacturing, Quality Engineering.
• Immense Knowledge of process improvement methodologies, risk management, CAPA administration, Supplier Quality Management and problem - solving techniques with the ability to act independently, analyze situations, recommend ideas and build consensus for solutions.
• Worked closely with R&D, Regulatory in supporting the development of new products and manufacturing process to achieve smooth, successful transfer to Manufacturing Engineering.
• Expertise in creating and implementing all Quality documents, including Validation plan, Gap analysis, Remediation Plan, Confidential, DFMEA, Test Protocols, Traceability Matrices, Test Method Validation (TMV), DOEs, Standard Operating Procedures (SOPs), Validation Master Plan (VMP) and Validation Summary Reports (VSR).

TECHNICAL SKILLS:

Cad Tools: Catia V5, Solid works, Pro-E and Auto cad

Statistical Software s: Mini Tab, Control Charts, SPC, SQC, DOE

Quality Tools: Lean Six Sigma, CAPA, Gage R&R, DFMEA, Confidential, FMEA, RCA, SCAR, FTA, Fishbone,5 why,5s, Kaizen

PROFESSIONAL EXPERIENCE:

Confidential, CA

Quality- Validation Engineer

Responsibilities:

• Work with Production, Manufacturing/Process Engineering in a sterile environment to create validation protocols, summaries and approvals to resolve process issues and implement changes on Class I & Class II Medical Devices.
• Perform Equipment Installation, Manufacturing Process Characterization, Operational Qualification, and Performance Qualification (IQ/OQ/PQ) activities, as well as Software Validation and Test Method Validation for manufacturing equipment and processes.
• Performed Gap Analysis and Remediated Risk Analysis documents of complex medical device delivery system from transfer project and developed it per Client requirements
• Collaborate, review and approve Validation Protocols, Validation Reports and Validation Master Plans. Author SOP’s and revisions related to validation to convey validation related requirements to engineering staff.
• Review specifications, drawings, contracts and supply agreements related to new process development.
• Coordinate corrective actions, maintain report files for NC’s and CAPA’s related to New Process Development and recently transferred processes.
• Provide quality inputs for new product development project.
• Experienced in validating equipment Installation, commission and performance Characteristics.
• Contributed additional line items to the Risk Analysis and DFMEA with the Product development team.
• Reviewed validation status of current equipment, systems, utilities and facilities.
• Performed documented periodic validation assessments, risk analyses and identified remedial activities.
• Review/Approve product Design change plan (PCR/PCO Process) and conform Design Verification/Validation activities performed before release to production ensuring product meet the predefined requirement. Review Engineering Drawings and component design specifications.

Confidential, Artesia, CA

Design Quality Engineer

Responsibilities:

• Created new CAD models of required Mechanical, Electro-Mechanical components and assemblies by using Catia V5.
• Produced high-quality engineering drawings, build packs and BOMs with GD&T standard and Catia V5.
• Designed and altered 3D models of Mechanical components such as propellers, condenser coils and mounting plates.
• Applied DFMEA and addressed root cause analysis to reduce the service failures caused due to material comparison, tolerance stack up and GD&T and ensured manufacturability of the products.
• Identified and implemented effective process control systems to support the development, Design Input Qualification.
• Developed quality plans, inspection procedures and control plans for new product development and delivery.
• Participated in project teams to review and develop clear and concise user requirements, product specifications, plans, usability studies, design verification and validation studies, risk management files and other relevant design control deliverables.
• Ensured documentation is aligned with corporate standards which includes FMEA, DFMEA, Manufacturing Process Characterization/ Confidential, product life cycles, Gage R&R.

Confidential

Manufacturing Engineer

Responsibilities:

• Created Manufacturing Work Instructions, new tool implementation and troubleshooting, Part Non-conformance Review and rework planning, scrap material processing, and hands on support of associates building the assemblies.
• Responsible for Product quality, including resolving quality problems, validating process developing and implementing process controls and inspection procedures using Confidential and other risk management methodologies.
• Participated in failure investigations and determined root cause, containment measures, corrective actions related to assembly process.
• Ensured Manufacturing process are compliant with all applicable regulations and Millstone quality system Requirements. Developed continuous improvement and lean manufacturing methodologies into production.
• Coordinated with cross functional teams for meeting schedules, project schedules.
• Participated in developing and maintain ISO 9001 procedures and documents for the manufacturing engineering department as required.
• Follow and execute corporate procedures including build to quarantine, rework jobs, expedite material from stores to the floor, first time buy, supplier approvals, protocols, test reports, and inspection method development.
• Employed statistical tools to track process capability (Cp & Cpk) and determine root cause of deviations from specification to implement process improvements.
• Develop quality plans, inspection procedures and control plans for new product development and delivery.
• Prepared SOPs describing validation policies, change control procedures, and equipment operation.