Design History Files (DHF), Remediation, Control Plans, ISO 13485

Sanjay Narayan

Email: ****************@*****.***

Phone: 682-***-****

Summary:

Senior Engineer in Medical Device Industry with experience in Process Validation, Design of Experiments, Design Verification, Process Improvement, CAPA Management, Risk Management and Quality Control in compliance with FDA regulations. Strong experience in implementation of Change Management/Control and Corrective Action and Preventive Action (CAPA) procedures. Assisted with Remediation Activities for including Non-conforming materials, CAPA, Preventive Maintenance, Calibration, Test Method Validation, and process updates. Experience in performing risk assessment, Risk Management and Gap Analysis.

TECHNICAL SKILLS:

Design History Files (DHF) Remediation Control Plans QSR 21 CFR Part 820 ISO 13485, ISO 14971 Test Method Validation (TMV) Gage Reproducibility & Repeatability Studies (Gage R&R) Fault Tree Analysis 5-Why Analysis Control Process Parameters (CPP) Statistical Process Controls(SPC) Minitab Geometric Dimensioning & Tolerance (GD&T) Six-Sigma, Lean & Kaizen Standard Operating Procedures (SOPs) Design of Experiments (DOE) DFMEA, PFMEA, FMEA Authoring & Executing Validation Protocols (IQ, OQ, PQ) CAPA Administration Root Cause Analysis (RCA) Closing Nonconformance Reports (NCR) & Nonconformance Material Reports (NCMR) Supplier Audits, Supplier Scorecards & Supplier Metrics.

Work Experience:

Flex Medical Jul 14 - Present

Irving, TX

Role: Sr. Quality/Compliance Engineer

Monitored yield, cycle time and contributed ideas for process improvements

Performed Design/Process FMEA’s and CTQ activities to establish controls for process variables

Streamlined new designs for manufacturing. Established Process Specifications.

Conducted design of experiments (DOE) to identify critical variables in a process and established design limitations.

Developed and implemented design changes to existing product and associated documentation updates to product design history files

Reviewed specifications and equipment design and builds at outside suppliers and determined machine acceptance and potential changes at equipment Factory Acceptance Tests

Used GD&T to interpret designs, blueprints and engineering drawings.

Conducted Reproducibility and repeatability studies on the part-to-part variation & analyst-to-analyst using Minitab.

Wrote equipment qualification protocols and reports (IQ and OQ).

Created Work Instructions, BOMs, Inspection Procedures and Routers for new and existing product implementation.

Applied FMEA, DMAIC and Lean 6 Sigma methods for product and process continuous improvements.

Investigated customer complaints, made reporting decisions, facilitated investigations, ensured completeness and consistency of documentation for complaints and present monthly complaint analysis reports.

Responsibilities included batch records review, complaint samples functional evaluation and analysis, communication with 3rd party suppliers to identify root causes at a sub-assembly and component level, and writing investigation reports.

Assessed Defect Rates, Complaint Rates, and severity to the patient via Post-Market Risk Analyses, and Health Hazard Evaluations.

Authored numerous technical documents to support FDA submissions.

Responsible for timely decision making regarding Medical Device Reports (MDRs), generating MDRs, and ensuring timely reporting.

Managed non-conformances, corrective and preventive actions and deviations.

Containment of non-conformance and identification and implementation of appropriate corrective action and/or preventative action.

Performed the evaluation and recommendation to the CAPA team to analyze and investigate CAPA’s.

Updated Risk Management documents and Essential Safety Requirements (ESR).

Lead cross-functional team through risk management of deviant product in the field.

Development and implementation of Quality Documents and initiatives to sustain and improving Quality Systems in accordance with ISO 13485 and QSR requirements

Prioritized cases for processing and prepares initial evaluation for critical and non-critical in order to assess quality status for expedited reporting

Developed and carried out performance tests on a device to characterize and document its safety

Executed Test Method Validation.

Validated the Test Fixtures, Test Assemblies and Gauges.

Created RM Plan and RM Report in compliance with QSR 820 and ISO 14971.

Reviewed the Design History Files (DHF).

Performed GAP Analysis and also developed the corresponding Remediation plan.

Executed approved process validation (PV) protocols using validated test methods

Developed protocols for Equipment and Process validation studies such as IQ, PQ, OQ; executed engineering studies and wrote reports in compliance with GDP

Led execution of Gage R&R study to determine part variations

Wrote, reviewed, & approved design verification & validation protocols (DOEs, IQ/OQ, PQ).

Led and actively participated in design reviews, ensuring representation from all functional groups.

Refined models, detailed drawings with GD&T and critical features and created inspection plan.

Developed verification and validation plan with insight from Quality and authored protocols and reports.

Managed Supplier Corrective Action Reports (SCARs), interfacing with both internal customers and the supply base to ensure effective actions are taken to reach closure.

Planned and prepared PPAP submissions on new products and engineering changes to meet customer deadlines and customer specific requirements

Core member of APQP cross-functional team working on the development of new and existing components to meet critical customer requirements and deadlines

Developed and maintained Control Plan and PFMEA documentation and procedures

Performed reliability characterization, acceptance testing, test parameters and sample size determination.

Maintained reliability test methods compendium; planned and executed design verification testing.

Baxter Feb 12 – Jun 14

Englewood, CO

Role: Quality Engineer

Applied problem solving tools/skills to effectively investigate nonconformances down to the root cause(s).

Participated in the Design Control process (Design Input, Design Output, Reviews, Qualification, Validation, etc.)

Managed risk analysis through tools such as as FMEAs, DOEs, capability analysis, etc.

Performed Qualification/validation activities from protocol development, to testing, to a completed final report.

Compiled and analyzed data, write/review/approve protocols, reports and make recommendations for changes and/or improvements and maintains appropriate validation documentation and files.

Support validation training, change control, periodic review of systems, equipment, and processes and support change management.

Ensure compliance with cGMP, QSR, ISO13485, MDD, and other applicable regulations/standards

Support the process of identification and implementation of CAPA

Support implementation SPC control system with Manufacturing and Quality Control

Completes internal quality system audits

Provides support necessary for supplier controls, including but not limited to: supplier audits

Develop functional Test Methods for design verification, process characterization, process validation, and finished product

Collaborate with Engineering and Manufacturing to investigate product problems, perform root cause analysis and identify possible corrective actions.

Creating and implementing procedures in the quality management system.

Participate in the review and disposition of nonconforming materials.

Creation and validation of manufacturing processes.

As required, perform supplier quality assurance functions including investigations, supplier corrective actions and supplier audits.

Conduct internal audits and report results.

Review manufacturing process and part deviations.

Worked with the SMEs and internal and external Reviewers to identify gaps and mitigate the risks

Set up design and development process as per 21 CFR 820.30 & ISO13485 requirements.

Responsible for verification of Design History file deliverables and review the deliverables

Performed assessments on previously validated process validation documents

Education:

Masters in Mechanical Engineering, Wichita State University, KS

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