Quality Engineer

Ravi Teja Adelli

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

Phone: 240-***-****

Summary:

Senior Engineer with over 5 years of experience in Medical device industry with diverse engineering experience including design and development, manufacturing/production, qualification and validation in Medical Device Industry. Extensive experience in Process Validation, Risk Management, Process improvement, Process controls, Continuous Quality improvement and six sigma projects in the medical devices industry. Strong Knowledge about the FDA regulations, 21 CFR part 820, Part 11 and ISO 14971, 13485. Expertise in risk based sampling and data analysis using Minitab. Performed PPAP, APQP, First Article Inspection (FAIR) and Incoming Inspections. Evaluated the process Repeatability and Stability and conducted Gage R&R studies. Experienced in implementation of Change Management/Control. Experienced in reviewing Corrective and Preventive Actions (CAPA) and highlighting and suggesting their mediation plans to mitigate the non-compliance.

Technical Skills:

Manufacturing, Process improvement, Root Cause Analysis, Statistics, Process & Test Method Validations, Process Mapping, FMEA, Quality Audits, Minitab, Process Improvement, Continuous Improvement, Assembly, SPC, Statistical Process Control and Process Capability, Failure Mode and Effects Analysis (FMEA), Process Validation, ISO 9001 cGMP, 21 CFR Parts 210, 211, 820, Design of Experiments (DOE), ISO 13485, Process validation including IQ/OQ/PQ that meets QSR, NCMR, SCAR, Quality Control Plans.

Work Experience:

Philips Healthcare Nov 14 - Present San Diego, CA

Sr. Quality/Compliance Engineer

Reviewed design histories files (DHF), performed GAP analysis and prepared Remediation Plans to fix the gaps identified

Served as quality liaison for R&D and completed quality activities for Design Change and New Product Development

Supported process and design improvement initiatives that focus on design input, design output, design verification, design validation and design transfer activities

Developed validation documentation (Requirements; Design Specifications; Risk Assessment; IQ, OQ, PQ and Reports) for manufacturing processes, systems, and equipment.

Reviewed test methods and design verification test plans.

Performed protocols for design verification, design validation, and aging that met various ISO standards.

Provided quality input to project design controls and Failure Modes Effects Analysis (FMEA).

Supported continuing engineering and new product integration quality activities. Primary activities include: pFMEA generation, developing IQ/OQ/PQ process validation protocols, and reviewing validation reports. Sustaining engineering functions to include: executing CAPA activities, supporting Supplier Quality initiatives, mitigating audit findings, supporting facility modifications, and integrating customer quality requirements with existing policies and procedures.

Responsible for the development and execution of Master Validation Plans, Risk Assessments, Installation Qualifications, Operational Qualifications, Performance Qualifications and Validation Summary Reports.

Ensured that Qualification Protocols, and Summary Reports were consistent with Good Documentation Practices prior to and after execution

Involved in validation process coordination within cross functional departments such as Technical Operations, Engineering, Quality Assurance, and Regulatory affairs.

Responsible for Creation, evaluation, and validation of product and process test methods

Wrote test methods for some existing work instructions and developed strategies to validate them

Evaluated test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives

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

IQ of new test equipment and validation of new software

Planning, strategizing, and executing validation activities

Incorporate FDA guidance and external standards into functional test methods and their validation

Responsible for maintaining Quality System Regulations including Document Control and Record Control

Developed documentation for all aspects of software validation including risk assessments, and quality and regulatory assessments

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.

Performed assessments on previously validated process validation documents

Merit Medical Feb 12 – Oct 14 South Jordan, UT

Project Engineer – Manufacturing Operations

Responsible for all aspects of Quality Assurance activities for manufacturing and engineering on multiple programs

Participated in the development and maintenance of PFMECA, PQP, QRD, Corrective Action / Preventive Action, First Articles, inspection plans, checklists, and SOPs

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

Evaluated product and process performance such as, pareto charts, statistical process controls, and process maps.

Developed and approved quality system documentation such as operations procedures and work instructions.

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

Supplier approvals and the continual evaluation of supplier performance including supplier audits

Communicate with customers and suppliers on issues related to product quality and performance

Implement quality and continuous improvement strategies within the quality and manufacturing system

Documentation Control: Engineer Change Order, Create, Review and Approval Specifications, FMEAs, BHRs

Validations: Development of test methods, process validation (IQ/OQ/PQ)

Risk Management: FMEA and fault tree analysis

Support and perform Quality Audits - Internal, External, FDA, BSI Regulatory Bodies

Statistical inspection sampling plans

Product Impact Assessments: Analyze and rationalize CAPAs, Nonconformance (NCs) & Observations, Failure Investigations and root cause analysis

Compiled NCR's appropriately when needed and identify the need to initiate CAPA

Performed process trending using control charts (X-Bar, R, p charts)

Perform investigation and analysis of validation outcome and implement effective solutions to solve issues, if any

Provide technical support/troubleshooting for process and equipment issues.

Performed risk management activities using Failure Mode Effect Analysis (FMEA) techniques to identify potential failure modes on pharmaceutical and medical device manufacturing equipment

Established and maintained procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability

Education:

Masters in Mechanical Engineering, California State University - Fullerton, CA

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