Engineer Quality Assurance

Rohini M. Reddy

**** ***** **** #***, ******* Meadows, IL Phone #: 847-***-****

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

Summary - Professional with 8+ years of experience in Bio-tech and Medical

Device industries in the areas of quality, development of Design History

Files and manufacturing. A result oriented engineer with excellent problem-

solving and communication skills. Actively support, participate and

embrace an empowered team culture. Experienced quality engineer with

expertise in commissioning, quality assurance, process engineering,

maintenance, calibration, vendor audits, and statistical analysis. Possess

thorough knowledge of 21 CFR Part 11, 210, 211 for pharmaceutical industry

and Part 820 for medical device industry. Proficient at preparing and

reviewing protocols for IQ, OQ and PQ, writing SOPs and summary reports. In

depth knowledge of FMEA, CAPA, fault tree analysis and other risk

assessment techniques for design and processes. Working knowledge of ISO

13485 and ISO 14971. Experienced in coordinating efforts among

contractors, validation group and quality department. Successfully

completed five Design History Files for legacy products.

EXPERIENCE Principal Engineer, Baxter Healthcare (November 2007 - Present)

. Evaluate and perform corrective and preventive action

responses for adequacy, including root cause and

timeliness. Resolve complex issues and escalates concerns

through management, as appropriate.

. Lead and participate in Pre and Post Milestone Reviews for

the Device Product Development Process for different

functional groups such as Global Infusion Systems, Access,

Tech Center, and Specialty Therapies.

. Lead and participate in Design History File Process

Assessments for different functional groups.

. Measure performance of the design process through

independent review of deliverables for compliance and

usability at future steps in the process, review of changes

in development plans and review of product performance and

support activities.

. Analyze, summarize and report on both product and process

performance indicators. Provide feedback to project teams

and functional management and identify opportunities for

improvement in project and process performance.

. Interact with all levels of internal management across

functions and project teams and serve as an expert able to

interpret and explain all Baxter CQPs, Quality Systems,

Interdivisional procedures, and global regulations as well

as assist in problem resolution in a timely manner.

. Knowledge of the global Regulatory and Quality requirements

for the manufacture and marketing of medical devices,

including ISO 13485, ISO 14971 and FDA's Quality System

Requirements/Good Manufacturing Practices.

. Trained on Lead Investigator Training, Risk Management

Training, Device Product Development Training, Design for

Six Sigma Training, Clearquest, Trackwise, and DOORS.

Compliance Quality & Technology Engineer, Maetrics Consulting Inc.,

(July 2006 - November 2007) Client: Boston Scientific

. Collaborated with suppliers to perform investigation and

root cause analysis for

Non-conformances that occurred during

validation/verification testing.

. Developed Operational Qualification (OQ) Protocols and

Reports and Product / Process

Performance Qualification (PQ/PPQ) Protocols and

Reports for manufacturing equipment.

. Developed Design Verification Protocols and Reports,

Product Specifications, ISO Testing

Protocols and Reports, and Design Validation Reviews

for PDP products in the fluid

management product family such as Fluid Delivery Sets,

Pressure Monitoring Lines,

Syringes, Contrast Management Systems, and Contrast

Injection Lines.

. Analyzed data with statistical analysis, root cause

analysis and the implementation of

corrective actions where necessary.

. Generated and resolved protocol discrepancies or

deviations.

. Observed validation policies, Quality Assurance

guidelines, and SOPs.

. Determined validation/verification requirements for new

products and changes to existing

products.

. Created Master Validation Plans as required.

. Performed Risk Assessment activities (DFMEA) for new

and/or changed products.

. Updated Product Performance specifications for new

and/or changed products.

Quality Engineer, Haemoscope Corporation, (March 2006 - June 2006)

. Developed, reviewed and managed validation/verification

protocols and reports.

. Provided on-going technical support to production line

for equipment, process, or design

related issues.

. Designed and implemented validation protocols for process

changes.

. Reviewed design changes for manufacturing impact and

compliance with regulations and

Standards.

. Provided engineering expertise to product development and

quality regarding supplier

qualifications and inspections.

. Worked in cross-functional teams to ensure quality system

requirements.

. Assisted in product development in design reviews and

incorporating risk management.

. Successfully completed the implementation of Bulk

Activator manufacturing process.

Validation Engineer, Manpower Professional (June 2003 - February

2006)

Client: Abbott Diagnostics Division

. Implemented new standards for primary and secondary assays

using standardization.

. Developed and executed Math Modeled Correlation Protocols

and coordinate with other

functional departments.

. Analyzed data with respect to validity criteria and

generate post summary reports.

. Ensured cGMP site policies and procedures were met.

. Trained and certified on TDx, IMx, and AxSYM - bench-top

instruments.

Test Method Validation Engineer, Client: Abbott Diagnostics Division

. Developed Test Method and In-Process Validation Plans/Protocols and

Reports.

. Executed approved protocols and coordinated with other functional

departments

. Generated and executed Qualification protocols

. Analyzed the Validation and Qualification data with respect to pre-

defined acceptance

criteria and evaluated the data with different

statistical techniques.

. Generated and resolved protocol discrepancies or deviations, as

appropriate through a

Validation Non-Conformance Report

. Observed validation policies, Quality Assurance guidelines, and

SOPs.

. Ensured that the validations meet the regulatory requirements

. Managed validations and control of end user laboratory processes by

scheduling activities.

. Knowledge of FDA Regulations of 21 CFR Parts 820, 210, 211, and 11.

. Knowledge of ISO 9001: 2000

. Saved 10,000 backorders for Digitoxin assay upon completion of the

full validation.

Quality Assurance, Client: Abbott Diagnostics Division

. Monitored abused drug assays in the Diagnostics Division using TDx.

. Ensured cGMP compliance and site policies and procedures.

. Knowledge of FDA Regulations of 21 CFR Parts 820, 601, and 808.

. Trained on the safety and hazard practices and understand material

safety data sheets.

Pharmacy Technician, Walgreens

Corporation (September 2002 - August 2003)

. Used the Intercom Plus computer system to process prescriptions and

assist patients.

. Entered patient purchases on pharmacy cash registers.

Process Engineer (Co-op), Goldschmidt Chemical Corporation (Aug. 2000

- Jan. 2001)

. Improved processes and instrumentation, flow, and piping drawings.

. Troubleshoot issues in the existing processes via discussions with

operators.

. Communicated with vendors, suppliers, and contractors for equipment

purchases.

. Provided technical support for equipment start-ups and updated

process hazard reviews.

. Worked with process engineers to ensure appropriate equipment is

installed in production.

. Implemented a Nitrogen Separator/Ultra-filter unit successfully in

the plant

EDUCATION University of Illinois - Urbana/Champaign

B.S. in Chemical Engineering, Graduated May 2002

PROJECTS Design, Optimization, and Analysis (Senior Design, UIUC)

Improved the design of an acetaldehyde production plant via

implementation of a heat exchanger network and optimization

of distillation column. Performed sensitivity and break-even

analyses to evaluate economic feasibility of the plant.

Methods & Software Evaluation (Gibbs Minimization)

Discussed limitations of the Kp method of reaction analysis. Reported

on the accuracy of GAMS software by comparing with results

from the method of Lagrange Multipliers.

AWARDS Sterling Merit Scholar, Fred S. Bailey Scholar, UIUC Dean's

List, Outstanding Student

Honor society, Circle of Excellence Award

Technical Languages: C/C++

SKILLS Software: LIMS, Standard OS (Windows/Unix), Office / Lotus

Instrumentations: HPLC, GC, MS, TLC, FTIR, and NMR.

Certifications: Configuration Management II certified (CMIIc)

(2010)

ACTIVITIES Member of American Institute of Chemical Engineers, Member of

American Society of

Quality

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