Professional Summary

Quality engineer with over 8 years of experience in medical device background with an emphasis in Quality System Integration,
Internal and External Standards Gap assessment, Quality Operations, Internal and External audit support.

 Performed EU MDR Quality System and Technical Documents Gap Assessments and Updated Quality System documents to
obtain EU MDR Quality System certification.
 Integrated Megadyne Medical Products Inc., Quality System with Ethicon Franchise Quality System.
 Deployed EtQ tool for Nonconformance, CAPA and Audit processes.
 Crated and updated Risk Management files aFMEA, pFMEA, dFMEA, Risk Management Plan and Reports.
 Performed Design Validation & Verification, Process Validations, Equipment Validation, Product Specification Updates for
Class I & Class II devices.
 Participated in Internal and External Audits and SME, Back Room Lead, Back Room Document Reviewer.

Technical Skills:

Standards and Regulations EU MDR, MDSAP Regulations, 21 CFR Part 820, ISO 13485, ISO 14971, ISO 10993, ISO
62366, ISO 15223, IEC 62304
PLM Tools WindChill,MasterControl, Adaptiv, EtQ, EpiCenter
Engineering tools Minitab, Solidworks, AutoCAD, Pro E, CATIA
Other Skill Root cause analysis, Closing Nonconforming Reports, CAPAs, Audit Observations, Six-sigma,
Lean & Kaizen, Gage R&R, Capability studies and SPC, Quality Plans

Work experience
Megadyne Medical Products, Draper, UT (Ethion – J&J Group) April 2017 to Present
Sr.Quality System Engineer

 Implemented Quality System tool EtQ for NCMRs, CAPA, Audit for Megadyne site. Created master data files to feed into
EtQ. Trained Megadyne associated to the new system.
 Crated protocols, test cases and completion reports to verify the proper deployment and functionality of EtQ for Megadyne
site.
 Supported implemented new PLM tool (Windchill) for Megadyne site. Created impact assessment questionnaire to support
the new Change Request tool.
 Integrated Megadyne Quality system with Franchise Quality system. This includes Escalation process, ICQA Process, Failure
Investigation process, Field Action, Quality System Management Review, Post Market Surveillance, PQSS DRB, Stop
Shipment, CER Process EtC.,
 Initiated Non-Conformance reports and CAPA’s as required. Facilitated root cause analysis session involving a cross
functional team of subject matter experts, resulting in effective corrections and corrective action plans.
 Identified and implemented effective process controls to support the development, qualification, and manufacturing of
products
 Created Work Instructions, update SOPs and ensured compliance with the governing rules and regulation
 Performed software validation for Megadyne Generator.
 Performed Quality System gap assessment for EU MDR and prepared Remediation Plans to fix the gaps identified.
 Updated quality system documents to comply with EU MDR requirements.
 Assisted in EU MDR Technical Document (TD) development strategy.
 Updated Risk Management Files to comply with new ISO standard revision ISO 14971-2019
 Crated Usability Specification and User Interface of Unknow Provenance documents to comply with usability Engineering
standards IEC 62366-1: 2020
 Created Manufacturing process Information documents for TD with the help of cross functional teams, component suppliers
and External Manufacturer.
 Performed gap assessment for European Union Harmonized Standards and created remediation plans. Crated
applicable/harmonized standards list to support Technical Document.
 Reviewed and updated Biocompatibility reports with the help of toxicologist. Drafted biocompatibility Memos for non-
patient contact products to meet EU MDR requirements
 Created Key Functional Element Documents (KFE) to reference in TD
 Supported Labeling team to updates IFUs and Labels
 Compiled the Technical Documents and supporting information to submit TDs to Notified Body (BSI)
 Responsible for gap assessment of TD files, updating Design Controls documents, provide feedback and remediation plan for
identified issues
 Participated in design reviews, design transfers, and in all aspects of the Design Control and risk management processes and
ensured customer requirements are met by incorporating engineering principles in robust design and
in design for manufacturability
 Performed risk management activities using Failure Mode Effect Analysis (FMEA) techniques to identify potential failure
modes on pharmaceutical and medical device manufacturing equipment
 Represented Development Quality in Process FMEA (PFMEA) Risk Review board as a board member and made sure the
PFMEA was built with consideration of all possible failure modes and causes from the Design FMEA.
 Authored major Risk Management documents such as Risk Management Plan and Report, Hazard Analysis, Design/Use
Failure Mode Effect Analysis (UFMEA) documents to identify all the potential Failure modes
 Experienced in Risk Management activities including updating Risk Management files to the current Abbott’s work
instruction with Post Market/ Supplier Quality/ Operations Quality / Customer Service and Product Performance teams for
multiple product lines
 Analyzed Website Complaints and traced it to existing Failure modes from various Risk Assessment Documents and
UFMEA, alongside documenting its severity and Risk Mitigation.
 Worked with cross functional groups in conducting analysis of NCMR's/ NCR's, with the purpose of evaluating the root
cause and finding the proper corrective actions.
 Reviewed technical documents such as drawings, Design History Files , V&V protocols and test reports, clinical reports,
Risk Management Files.
 Assisted with labeling and IFU gap assessment and updates.
 Performed risk evaluation of findings to define criticality and prioritize remediation activities
 Performed gap analysis on multiple products and their Design History Files (DHF). Reviewed documentation throughout the
entire design life cycle.
 Used statistical techniques, risk analysis, Gage R&R, Cpk, ANOVA and DOE and resolved quality issues using Cause &
Effect Diagrams, FMEA's and Root-Cause Analysis tools.
 Reviewed technical documents such as drawings, Design History Files , V&V protocols and test reports, clinical reports,
Risk Management Files.
 Reviewed internal documentation for compliance with regulations and industry guidelines.
 Established regular communications on progress, process changes, risks and issues with the Supplier Quality.