Manufacturing Engineer
Resume:
Anirudh
***********@*****.***
Professional Summary
Senior Manufacturing Engineer in Medical Device industry with expertise in Process Validation, Test Method Validation, Equipment Qualification, Quality Assurance, Inspection and Testing, Verification, Technical Documentation (IQ/OQ/PQ) in Compliance to FDA 21 CFR and GxP regulations
Experience working on processes such as Crimping, cutting, welding, drilling, coil winding, molding using polymer and silicone material, laser etching and sterilization processes
Create qualification and validation deliverables, such as validation project plans, risk assessments, validation (e.g., IQ, OQ, and PQ) protocols, commissioning plans, commissioning and validation summary reports, etc.
Strong experience in development of Validation Protocols and reports for Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) for the related equipment and applications.
Review current GMP documents for compliance to company SOPs, quality systems and regulatory requirements
Quality engineering experience with CAPA, Control Plans, FMEA's, Process Validation, IQ, OQ, PQ, Equipment Validation and corrective action activities
Excellent knowledge on ISO 13485, ISO 14971, 21 CFR 820 standards, specialized in execution & closeout of NCMR and CAPA and also conducting Root Cause Analysis (RCA).
Experience in New product development, Risk assessments, CAPA System Monitoring and system trending.
Experienced in preparing Standard Operating Procedures (SOPs) and Design History Files (DHF).
Remediation of Design History Files and Design Controls.
Conducted Test Method Validation (TMV) and Product & Process Trend Analysis. Executed and summarized Validation Protocols (IQ, OQ, PQ) in a GxP environment.
Excellent working knowledge of Fault Tree Analysis, Why-Why, 5-Why methodologies and Fish Bone Analysis. Expertise in handling Supplier Quality Management issues.
Well versed with developing Supplier Metrics and Supplier Scorecards.
Conducted Root Cause Analysis (RCA) at Supplier level and prepared Supplier Corrective Actions report (SCAR).
Proficient in implementing Good Manufacturing Practices (GMP) and Good Documentation Practices
(GDP).
TECHNICAL SKILLS:
Manufacturing Process Development & Optimization - Tooling & Fixture Design - Design Control - Design Input/ Output - Design V&V - MRP - ISO -cGMP - Assembly Operations - Time Studies - Capacity & Layout Planning - Quality Assurance - DOE - Six Sigma - PFMEA - SPC - Minitab - CAPA Metrics - Root Cause Analysis - Data Analytics - GD&T - Kaizen - Lean - SCAR - 5S - VSM - Corrective Action/Preventive Action
- Design and Operational Qualifications - Validation Plan - Risk Management Plan - FDA Regulations Project Details:
MicroAire, Charlottesville, VA
Manufacturing Engineer-II (Jun’15 – Present)
Managed, executed and documented the qualification and validation of manufacturing equipment, processes, and manufactured components to meet the requirements
Created qualification and validation deliverables, such as validation project plans, risk assessments, validation (IQ, OQ, and PQ) protocols, commissioning plans, commissioning and validation summary reports, etc.
Effective and passionate CAPA investigator for root causes analysis and impact assessment of nonconformance, including CAPA plan design, and effectiveness verification of CAPA implementation for quality issues
Consistent quality and CAPA processes and records compliance with regulatory requirements
Meeting corporate quality, CAPA and Audit goals
Responsible for initiating, implementing and completing change control, deviations, investigations, impact/risk assessments, root cause analysis and CAPAs
Experienced in validating different types of test methods (Attribute Test Method, Variable Destructive Test Method, Variable Non-Destructive Test Method, Analytical Test Method and Inspection Test Methods, Mechanical and Dimensional Test Methods)
Authored and executed IQ/OQ/PQ protocols and wrote reports
Maintained and updated Validation Master Plan and related documentation
Reviewed the Design History Files (DHF)
Responsible for Creation, evaluation, and validation of product and process test methods
Authored test methods for some existing work instructions and developed strategies to validate them
Experienced in in statistical data analysis using Minitab (Gage R&R, Anova studies) and Distribution Analyzer
Prepared detailed inspection documentation such as written descriptions of inspection results including deviations from engineering specifications
Supported Manufacturing team with Change Requests, Deviations, Identifying Non-Conforming Materials, Issuing and Closing NCR forms
Provided technical support on components, material methods, systems and equipment.
Coordinated/developed validation studies on equipment & processes
Risk Management, DFMEA, and PFMEA support
Performed root cause analysis and implemented corrective action
Corrective & Preventative Action - creative problem solver, assess problems, implement timely and effective solutions.
Identified and coordinated activities required to complete qualification and validation activities, including reviews with Quality, obtaining signature approvals, and executing qualification protocols or validation project plans
Develop Standard Operating Procedures (SOPs) for test methods and laboratory instruments.
Experienced with process validations activities including Characterization of critical process parameters, designed and reviewed protocols, supervised sampling activities and analyses, and prepared summary reports
Prepared SOPs describing validation policies, change control procedures, and equipment operation.
Involve in risk assessment, 21 CFR Part 11 assessment, and review validation plans.
Reviewed internal documentation for compliance with regulations and industry guidelines Carticept Medical, Alpharetta, GA
Manufacturing Engineer (Aug’13-May’15)
Created project plans to execute validation activities (IQ, OQ, PQ) and developed testing protocols.
Worked with teams consisting of manufacturing engineers & technicians in carrying out compliance activities to fulfill requirements for GMP, ISO 13485 and FDA regulations.
Reviewed and provided assessments of process validation documentation (IQ, OQ, PQ) and Control Plans.
Responsible for design verification test activities for large medical device programs including; test method development, creating test protocols, writing technical reports, sterilization and packaging studies and test method validation submissions.
Completed validation activities related to Test Method Validation to support FDA audit related corrective actions.
Wrote the division quality trending process and determined metrics used for worldwide complaint and quality data analysis.
Performed multiples IQs.
Led individual test method validation (TMV) studies.
Authored TMV studies, established pre-defined acceptance criteria, proctored TMV data collection, performed statistical analyses on results, and authored study reports.
Authored Validation plans and OQ, PQ documents and executed OQPQ.
Developed remediation plans and drove remediation through the CAPA system for the role out of new/revised Quality Policies and Standards.
Designed experiments using DOE methodology and analyzed the test results using statistical tools.
Facilitated resolution of reactive quality initiatives; containment/root cause/corrective actions, customer issues, etc.
Supported development and updating of PFMEA and related risk assessment documentation.
Provided engineering support to close numerous CAPA projects.
Developed CAPA plans as a result of regulatory observations, audits, customer complaints, and and/ or system gaps.
Drove CAPA remediation efforts to close Nonconformance reports.
Managed and updated Design History Files for various medical devices.
Created or modified SOPs as part of qualification process and trained operators.
Developed internal and supplier quality system procedures and processes to align them with company’s Standard Operating Procedures (SOPs).
Developed Supplier Scoreboard Metrics covering aspects such as Productivity, Safety, Cost, Overall Effectiveness etc.
Analyzed the Supplier Scorecard and evaluated quality issues with the supplier.
Maintained Supplier Corrective Action Records (SCAR), Design History Records, Quality Inspection Procedures (QIP) and Supplier Audit checklists
Created Value Steam Map (VSM Map)
Performed risk assessment and FMEA for test methods, and instrument re-validation
Managed laboratory and coordinated compliance to cGMP and FDA Standards for medical devices
Revised SOP's and test methods.
Implemented Statistical Process Control (SPC) to reduce the variation and improve the Cpk on various processes.
CR Bard, New Providence, NJ
Process Engineer (Mar’10-Jul’13)
Responsible for Design Review, Inspection Planning, Inspection Method Development and Adequacy, Process Validation and Product Disposition.
Reviewed test protocols and specifications with quality technicians and perform Gage R&R studies
Supported the Design Input review and wrote DV protocols
Developed PFMEAs, managed/developed control plans, evaluated/improved process capability for Critical to Quality (CTQ) characteristics, validated measurements systems using statistical tools such as Gage R&R.
Improved the process capability and implemented an Excel and Minitab based data management system reducing the time required for data collection and analysis.
Analyzed, generated, and reported findings from Cp/Cpk studies, window studies, DOE’s (design of experiment), first article inspection reports and other analytical/statistical methods
Remediated Design History File to meet current standards and insure conformance to the quality system.
Performed test method validations (Gauge R&R studies - Minitab).
Gained experience in using Why-Why Analysis, 5-Why Analysis and Fault Tree Analysis.
Employed Statistical and Data Analysis tools to perform Stability and Reliability studies.
Performed regulatory documentation and compliance evaluations such as CAPA, customer complaints, and investigations.
Performed and documented CAPAs investigations for all the customers and suppliers.
Developed and tracked CAPA process metrics to support improvement activities.
Approved SCAR responses to supplier quality issues a verified the effectiveness of supplier actions on inspections and supplier audits.
Directed inspection of products to company, supplier and/or customer activities.
Developed Gage R&R study, Fish Bone Analysis and Fault Tree Analysis.
Maintained and complied with the SOP's. Was responsible to review applicable QMS procedures to ensure adequacy to business and external regulatory requirements
Set up Gauge R&R study to establish equivalency for new instruments and validate test methods. Data was analyzed using Minitab.
Implemented test methods, and trained lab personnel on the new test methods.
Created Process Map of the current Non-Conforming Report process to identify the gaps
Was responsible for IQ, OQ, EQ, and test methods re-validations
Performed FMEA on products and processes to identify and mitigate risks
Designed validation and reproducibility studies by using gage R&R for final product testing equipment Education:
Masters in Mechanical Engineering, University of Texas, TX
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