Tarun Krishna

advym4@r.postjobfree.com +1-650-***-****

**** ***** **, *** ****, CA 95135, USA

www.linkedin.com/in/tarun-krishna-93601a246/

PROFESSIONAL SUMMARY

Highly skilled Quality Systems engineer with 6+ years of experience in manufacturing, production, quality, writing protocols for validation, planning and control. Ability to lead a team towards the prescribed goal.

Experience in Quality Engineering, QMS, Lean Manufacturing, Process Improvement, CAPA Management, New Product Process Verification & Validation, Risk Management and Quality Assurance in compliance with FDA regulations.

Provide support with BOM and routings validation. Perform time studies as required to ensure standard time and standard cost accuracy in our SAP MRP system.

Assisted design engineers in conducting Design for Manufacturing (DFM) studies for New Product Introductions (NPI) and New Product Development (NPD) projects.

Contributed in design modifications to facilitate manufacturing operations or quality of products.

Checked drawing plots versus the project input for correctness and conformance to standards, and work with engineers regarding model accuracy, design, drafting standards, and ECO/ECR documentation.

Experienced in change control procedures including design changes and production changes following ISO 13485 standards. Worked cross functional teams in manufacturing, quality and packaging as required.

Performed Design of Experiments (DOE) and developed work instructions (WI).

Run the SLA machine (3D printer) to produce prototype parts per engineering requests.

Develop 3-D models of the product and performance for detail product analysis structural analysis, tolerance stack analysis.

SKILL MATRIX

Design Control, Design Verification and Validation, QSR 21 CFR Part 820 ISO 13485, ISO 14971, Control Plans, Standard Operating Procedures (SOPs), Design History Files (DHF), Design of Experiments (DOE), EU MDR, CAPA, DFMEA, PFMEA, FMEA, New product Development, Supplier Audits, Gage Reproducibility & Repeatability Studies (Gage R&R), Fault Tree Analysis, 5-Why Analysis, Statistical Process Controls(SPC), Minitab/Data in R, Geometric Dimensioning & Tolerance

(GD&T), Six-Sigma, Lean & Kaizen, Process Validation Protocols (IQ, OQ, PQ), Implementing GxP (GMP, GDP, GLP), CAPA Administration, Root Cause Analysis (RCA), Closing Nonconformance Reports (NCR) & Nonconformance Material Reports

(NCMR).

PROFESSIONAL EXPERIENCE

Sr. Quality Systems Engineer Sep 2021 - Present

Abbott Laboratories Menlo Park, CA

Responsible for maintaining and updating CAPA business processes using CATS Web server. Ensure all deadlines are met for action items.

Supported development of new modules, features, and software upgrades with coordination of impact to software validation, QMS procedures, system administrators, and end users.

Developed optimum state of QMS in regard to processes for creating, maintaining and reporting master data for current and future business needs

Supported the development and execution of CAPA plans to address identified deviation root causes and compliance/quality gaps.

Developed and executed IQ, OQ, and PQs for manufacturing processes and supporting manufacturing equipment and instrumentation.

Developed PFMEAs, Test Method Validation, and process validation documents.

Identified gaps and opportunities to further develop QMS, coordinated and implemented enhancements, including procedural updates, release and implementation.

Identified opportunities for re-design/design of basic equipment, tools, fixtures to improve inspection processes and reduce risk

Identified systemic QMS issues, risks & negative trends (WC/Site) and recommend / implement corrective and preventative actions

Developed and validated inspection routines on high end visual measurement systems to help improve efficiency and drive down turnaround time in receiving inspection.

Identified and implemented improvement opportunities to increase the efficiency and effectiveness of the QMS.

Executed value improvement projects that focused on eliminating waste and decrease component costs.

Responsible for leading the CAPA process, QMS and Audit support activities

Identified non-conformance trends and develop technical investigation plans. Investigated and analysed supplier(S), Customer(s) and Internal complaints and non-conformances.

Planned, coordinated, developed and executed test protocols, experiments, process characterization and process validations on new and revised products and processes.

Coordinated efforts to design, develop and validate manufacturing processes using tools such as Design of Experiments (DOE), Measurement System Analysis (MSA), Failure Modes and Effects Analysis (FMEA), Statistical Process Control (SPC), and capability analysis.

Reviewed technical documents such as drawings, Design History Files - F&DR, V&V protocols and test reports, clinical reports, Risk Management Files - FMEA, DCRM – plans.

Developed PFMEAs, Test Method Validation, and process validation documents and remediation

Established design inputs/outputs, meeting reliability outcomes, Design Verification & Validation, Process Characterization & Validation,

Assessed Critical to Quality (CTQ) parameters and risk assessment variables as part of the decision-making processes to support predictable product design and flow

Planned, coordinated, developed and executed test protocols, experiments, process, characterization and process validations on new and revised products and processes

Responsible for product quality, including resolving quality problems, validating processes, developing and implementing process controls and inspection procedures using PFMEA and other risk management methodologies.

Analyze/review effectiveness of preventive and corrective actions. Reviewed root cause investigation according to an established process (DOP, SOP).

Quality/Manufacturing Engineer Sep 2019 –Aug 2021

PHILIPS Gainesville, Florida

Project is on creating BOM (Bill of Materials) and production line structures using Agile (9.3.4) for Technical Product Documentation for new manufacturing unit in Pune (India).

Management of commercial change initiatives in LCM as approved by Change Review Board.

Creating BOM analysis and Redline markups for Test Procedures and Test Sheets carried out in manufacturing BOM for change and revision control.

Coordinating with project engineers for production line transfers through the change control system.

Creation of new BOM structures as per revised manufacturing methodology and creating new DMRs with required attachments in Agile. Reviewing the production line in SAP systems.

Experienced in Label Designing following the latest EU MDR (European Medical Device Regulation) product regulatory compliance for shipping, rating, warehouse standard etc. using Code Soft.

Updating the drawings with new revisions and changes in EDMS. Good knowledge of documentation, Current Good Manufacturing Practices (cGMP) in medical device industry, management of statistical procedures and knowledge of computer tools required.

Assisted in transitioning from Medical Device Directives (MDD) to EU MDR by completing gap assessments on Technical.

Involved in updating the Design Change Plan (DCP) and risk assessment files for various MRI coils by taking inputs from cross functional teams.

Working cross functional team with R&D, Quality and Manufacturing departments during the concept, prototyping and release of new products.

Responsible for accurate assessments of cost and production impacts for LCM/LCE changes.

Initiating ECR and reviewing the required changes that modifies the Manufacturing Change Order (MCO), Document Change Order (DCO).

Authoring and implementing Engineering Change (ECO) & SOPs utilizing Arena PLM tool, managing Design Requirements traceability & defects mitigation.

Reviews ECO’s and routes to the appropriate departments for approval for updated drawings and the appropriate documentation in the ERP system.

Implementation of ECR results and approvals with Engineering Change Notify (ECN). Utilizes knowledge of JEM Technical methods and procedures to ensure that the ECO process proceeds effectively and efficiently.

Highly sophisticated in lean manufacturing methodologies such as Six Sigma following DMAIC approach and statistical process controls.

Risk analysis and risk evaluation process aligning with ISO 14971:2007.

Reviewing and augmenting SOPs to enhance Design Control and Risk Management Processes.

Management of packaging configuration/release activities in support of PDLM project and experienced in creating project specifications and work instructions.

Manufacturing Quality Engineer Nov 2018 - Aug 2019 ZIMMER BIOMET - Warsaw, Indiana

Hands-on experience in manufacturing medical devices, testing, injection molding and in troubleshooting various medical devices.

Manufacturing and Quality control of Knee parts in medical industry. Reliability engineering for components, materials, products and systems. Equipment setup and line trouble shooting.

Support material review board (MRB) meetings and follow up with actions regarding nonconformance to evaluate risk for re-work instruction to parts, instrument, and scrap reduction.

Provide support with PLM software with implants lifecycle of a product efficiently and cost effectively from ideation, design and manufacture through service.

Write/executed process validation protocols for Medical Device Environment such as Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Test Method Validation (TMV).

Functional excellence leader driving QMS elements to implementation according to regulations requirements from FDA- QSR 21 CFR 820, 21 CFR Part, ISO 9001, 14971, 13485, CMDR, MDD. Experience working with EU MDR.

Knowledge of product validation, medical regulatory standards of ISO 13485/9001 and Standard regulation of FDA. Supported and performed Quality Audits & Assessments for certifying operators - Internal, External, FDA, BSI Regulatory Bodies.

Monitoring and testing equipment and directing validating activities. Execution of traceability matrix and deviation reports. Assisted in process validation during the product lifecycle approach.

Set up Gauge R&R study to establish equivalency for new instruments and validated test methods. Data was analyzed using Minitab.

Risk analysis and risk evaluation process aligning with ISO 14971:2007. Evaluating the User Requirement Specifications (URS) relating the validation with medical implants performing risk analysis through post market surveillance.

Use of Enovia software for creating NCR/NCE reports.

Providing support with CAPA (Corrective and Preventive Actions) according to the FDA regulations.

Trained in all stages of CAPA including Initiator, Investigator, Action Planner, Implementer and Effectiveness verifier.

Provide support with bill of materials and scheduling the routings according to the order.

Designing the fixtures used in blasting and polishing the parts. Review new equipment, correct settings and control points. Driving efforts to ensure that Design Requirements are verified & production release is validated.

Providing support for the manufacturing errors and updating the blueprints, assigning the work instructions required and work criteria’s to be followed.

Quality Associate Engineer Apr 2017-Nov 2018

BD Covington, GA

Wrote, Reviewed and approved Engineering Change Orders and Engineering Change Records, Product Development History documents (DHR), IQ, OQ, PQ for accuracy and correctness.

Developing, review and updating inspection plans for new material in SAP as per AQL.

Involved in design dossier refer to technical documentation for class III device.

Developed FMEA’s on manufacturing process for remediation and FDA Quality System compliance for a Class III medical device.

Extensive field work from beginning phases of mobilization through actual project construction, assembly, installation of structures/systems and equipment and final testing of operations and safety.

Provide support with BOM (Bill of Materials) and routings validation. Perform time studies as required to ensure standard time and standard cost accuracy in our SAP MRP system.

Conducted Process Failure Mode Effects Analysis (PFMEA) to identify and evaluate potential process failures in design/assembly of Medical Devices. Executing Hazard Analysis in risk management plan.

Structural problem techniques (5whys, FMEA) and statistical methods (stress analysis, hypothesis testing) for data driven analysis and decisions.

Assisted product development in quality control procedures, development of test protocols for new equipment procurements (IQ/OQ/PQ), and introducing best practices to manufacturing.

Reviewed validation (IQ/OQ/PQ/PPQ/TMV) and provided technical input to ensure validation reports were qualified to company and regulatory requirement.

Worked cross functional with design and manufacturing teams to adhere product requirements. Experienced in handling heavy machinery.

Design of experiment analyzed system design to develop efficient tests methods that generate objective evidences of Verification.

Maintaining process integrity by developing and updating policies, procedures, methods and guidelines.

Experience in GD&T, DFMEA and PFMEA techniques for better manufacturing. Junior Mechanical Engineer Jul 2014 - Dec 2015

TECHNO PAD ENGINEERS – Hyderabad, Telangana

Manufacturing and development of mechanical seals for pumps and compressors.

Contacting the customers for specified sizes of seals as per their required dimensions for the compressors and pumps.

Checking the dimensions and the materials (Cast Iron) of the required seal for precision.

Detail drawing preparations for proto typing and manufacturing feasibility studies using Pro/Engineer.

Completed investigation of product device complaints per customer communication, Device Master Record (DMR), Quality Control Instructions (QCI) and Device Specifications, etc.

Preparing and submitting design verification plans and reviewing test reports with product validation teams.

Leading design visualization efforts with 3D CAD models and essential component and assembly details to explore multiple design options.

Developing innovative manufacturing techniques to meet all requirements for performance, reliability, serviceability, warranty, cost and manufacturability.

Developing engineering design concepts for components and mechanical assemblies that have tough requirements for usability, precision, reliability, cost and schedule.

Conversion of models from 2D to 3D, migrating 3D models from other software's to Catia V5R20.

Performing stress analysis and static structural analysis on the final product using ANSYS 16.0.

Working on the client’s place for the installation of the product and rectifying any errors generated.

Make sure the products were produced on time as well as of superior quality. EDUCATION

Master of Science in Mechanical Engineering – University of Texas – Arlington – Jan 2017

Bachelor of Technology in Mechanical Engineering - JAWARLAL NEHRU TECHNOLOGICAL UNIVERSITY, Hyderabad, Telangana – Jun 2014

Contact this candidate