Medical Device Quality & Validation Engineer

Jahnavi Achanta

*********@*****.*** 408-***-****

Quality & validation Engineer

LinkedIn-www.linkedin.com/in/jahnavi-achanta-0409383a9

Visa: H4EAD

Professional Summary:

Quality and Validation Engineer with 7+ years of experience in medical and pharmaceutical device manufacturing,ensuring compliance with FDA, EU MDR, cGMP standards.

Expertise in CAPA,NCR and Root Cause Analysis(RCA)to resolve quality issues, drive improvements, and ensure regulatory compliance.

Hands-on experience in Computer System Validation (CSV), equipment qualification, and process validation in compliance with cGMP and FDA regulations.

Proficient in IQ, OQ, PQ and process validation for equipment, utilities and manufacturing processes per ISO 13485 and cGMP standards.

Skilled in Test Method Validation (TMV) for medical devices, ensuring accuracy, precision, and reliability of analytical and manufacturing methods used in product testing and validation.

Executed commissioning, qualification, and validation (CQV) activities for GMP process equipment including bioreactors, CIP/SIP systems, filtration skids, process tanks, and transfer systems in regulated manufacturing environments.

Reviewed and maintained (DHF) records including design inputs, design outputs, verification, validation, risk management, and design review documentation.

Skilled in risk management, CAPA, NCR, root cause analysis and Test Method Validation (TMV).

Adept at developing and executing SOPs, Work Instructions and validation protocols.

Proven ability to collaborate with cross-functional teams for product verification, compliance and process optimization.

Proven expertise in Risk Management and FMEA, identifying failure modes and implementing preventive measures for patient safety.

Expertise in QMS compliance,including GDP,SOPs, Change Control, Deviation Management, and documentation for regulatory audits.

Conducted FDA, ISO13485 and supplier audits, ensuring compliance, identifying risks,and driving continuous improvement.

Strong knowledge of Supplier Quality Management (SQM), including supplier qualification, risk assessments, and CAPA implementation.

Hands-on experience in clean room validation, aseptic processing, and packaging validation per FDA guidelines.

Skilled in statistical processcontrol (SPC), DOE, and data analysis (Minitab) to optimize processes and improve product quality.

Skills:

Validation Expertise

Computer System Validation (CSV), Equipment Validation, Process Validation, Cleaning Validation, Method Validation, Risk-Based Validation, IQ/OQ/PQ, Validation Master Plan (VMP), Traceability Matrix

Regulatory Standards

GxP, GMP, GAMP 5, 21 CFR Part 11, EU Annex 11, ISO 13485, EU MDR, FDA QSR, EMA, MHRA, Notified Body Audit Compliance

Documentation & Quality Systems

URS, FRS, DS, Validation Plans, SOPs, Test Scripts, Risk Assessments, Deviation Reports, CAPA, Change Control, Audit Trail Reviews, Data Integrity Assurance

Systems & Platforms

LIMS, QMS, LMS, MES, ERP (SAP, Oracle), Electronic Batch Records, eTMF, PLM (Agile, Windchill), Empower, Laboratory Information Systems

QMS / Compliance Tools

TrackWise, Veeva Vault QMS, MasterControl, Greenlight Guru, Documentum

Cross-Functional Collaboration

Quality Assurance, Regulatory Affairs, R&D, Manufacturing, IT for validation strategy, audit readiness, and continuous improvement initiatives

Other Tools

MS Project, MS Visio, Splunk, Service now, Incident Management

Experiences:

Client: Robling Medical, USA Feb 2024 – Present

Role: Quality Engineer

Responsibilities:

Led, authored and reviewed Test Method Validations (TMVs) for both manufacturing and R&D ensuring compliance with industry standards.

Participated in Design Transfer activities to ensure seamless transition of medical devices from R&D to commercial manufacturing in compliance with regulatory requirements.

Supported Design Verification and Validation (DV&V) activities and ensured test protocols and reports were properly documented within the DHF.

Executed Sterilization Validation activities for medical devices in compliance with FDA and GMP requirements.

Supported Safety Risk Assessments, Traceability and Control measures, Product Safety Review Report, Quantitative Hazard Assessments (QHA) along with dFMEA and design reviews.

Responsible for first article inspection, incoming and in process inspections and lot release testing, including sampling strategies and test methods.

Worked with Manufacturing Engineers in developing process validation protocols, pFMEAs, quality plans, manufacturing procedures, inspection plans, and specifications.

Utilized SAP to manage production orders, material master records, inventory transactions, and batch documentation in a GMP-regulated manufacturing environment.

Issued and tracked Supplier Corrective Action Requests (SCARs), ensuring timely root cause analysis, effectiveness checks, and closure.

Performed supplier audits (onsite and remote), identifying compliance gaps and driving corrective actions (CAPA), improving supplier quality performance and audit readiness.

Experienced in Measurement System Analysis and statistical data analysis using Minitab for Gage R&R both crossed and nested.

Validated different test methods (Attribute Test Method, Variable Destructive Test Method, Variable Non-Destructive Test Method and Inspection Test Methods, Mechanical and Dimensional Test Methods).

Executed and supported CQV activities (IQ/OQ/PQ) for manufacturing equipment, cleanrooms, and utilities used in medical device production

Develop Technical Studies, Risk Analysis, Process Mapping, DOE’s, Gap Analysis, Statistical Rationales, Discrepancy Reports, among other documentation.

Responsible for Customer Complaint Investigations, CAPA projects, Non-Conformance Reports, Cost Reduction and Continuous Improvement projects, Quality Systems Excellence among other projects.

Experience conducting audits, risk analysis, risk assessments, PFMEA, DFMEA to corporate quality systems in the class II medical devices.

Supported change control activities for supplier process, material, or manufacturing changes.

Established and monitored baseline tools and metrics, including Cpk and Statistical Process Control (SPC), to measure process performance and corrective action effectiveness.

Conducted gap analysis and remediation for SOPs, Design History Files (DHF), Design Inputs and Outputs, Design Verification, and Design Validation documentation.

Supported Quality Audits–Internal, External, FDA, TUV Regulatory Bodies

Experienced working on RoHS and REACH exemptions for EU

Client: Globus Medical, PA, USA Mar 2020 – Nov 2023

Role: Process Validation Engineer

Responsibilities:

Developed strategies for cleaning cycle development studies, and cleaning validation protocols.

Developed and validated sterilization processes (EtO, steam, radiation, dry heat) per FDA/ISO standards

Responsible for compilation of data, interpretation of results, and preparation of final reports for cleaning validation activities.

Performed Computer System Validation (CSV) activities in compliance with 21 CFR Part 11 and GxP standards.

Collaborated with cross-functional team to create risk assessments pFMEA’s for several process equipment.

Executed commissioning, qualification, and validation (CQV) activities for GMP process equipment including bioreactors, CIP/SIP systems, filtration skids, process tanks, and transfer systems in regulated manufacturing environments.

Coordinated with Engineering, Manufacturing and Quality for timely approvals of CQV deliverables.

Performed peer review of CQV protocols.

Trained junior engineers on the execution of cleaning validation and other qualification protocols.

Involved in executing SAT protocols, Design Qualification and (IQ/OQ/PQ) protocols.

Author documents such as HVAC IOQ, EMS IOQ, AVS, incubators IOPQ, freezers IOPQ for 12 E GMP facility.

Troubleshooting CIP processes and new cleaning equipment with site-engineering group.

Trained manufacturing operators on process equipment SOP’s.

Assisted investigation of non-conformity and authored CAPA’s.

Coordinated with Meteorology department to schedule Calibration and Maintenance activities.

Assisted in the development of maintenance procedures for new equipment.

Client: 3M Healthcare, MN, USA Aug 2018 – Feb 2020

Role: Validation Engineer

Responsibilities:

Performed equipment and computer system validation (CSV) for medical devices, diagnostic instruments, and laboratory systems in compliance with FDA regulations.

Authored and reviewed validation protocols (IQ, OQ, PQ), SOPs, risk assessments, and traceability matrices ensuring alignment with GAMP 5 and QMS requirements.

Executed process validation, method validation, and cleaning validation for critical medical device manufacturing and testing processes.

Validated electromechanical and software-driven devices including imaging systems, IVD analyzers, and critical care equipment.

Conducted risk-based validation and gap assessments, ensuring product quality, safety, and regulatory compliance throughout the device lifecycle.

Collaborated with R&D, Quality Assurance, Regulatory Affairs, and Manufacturing teams for validation strategy and implementation.

Supported internal audits, CAPA, and regulatory inspections (FDA, ISO, CE, DCGI) by providing compliant validation documentation.

Ensured data integrity, audit trail verification, and electronic record validation as per 21 CFR Part 11 and Annex 11.

Participated in change control management, re-validation, and system upgrades for production and laboratory equipment.

Delivered end-user training on validation best practices, documentation, and regulatory compliance.

Education:

Bachelor’s of Engineering-2008

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