Quality Assurance Engineer

Professional Summary

. Focused leader with extensive experience in the area of Quality

Assurance, and Manufacturing. Expert in building highly effective

teams to help the organization in delivering world-class medical

device products to market.

. Leadership: Various leadership roles in the area of Quality

Assurance / Manufacturing with the main focus of establishing

processes and operating policies to contribute in shortening product

development life cycle, maximizing efficiency and productivity of

the departments; managing over 75 headcounts.

. Organizational Excellence: Highly skilled in budget planning,

assessment of personnel needs and hiring of top notch human

resources for the department and training of personnel to be updated

with the latest tools to maximize the productivity of the

department.

. Worked as a team with various functional disciplines such as Electrical /

Mechanical Development, Test Engineering (ATE), Manufacturing, and

Marketing.

. Heavily involved with Contract Manufacturers globally (ex: Malaysia,

India, Sweden)

. Head of Quality Assurance Engineering for implantable products.

Responsible for internal audit, ensuring compliance to company

procedures. Flagged and addressed compliance issues.

. Head of Software Quality Engineering organization to support the

verification and validation of implantable and external products.

. Member of Product Improvement Board as part of the CAPA system

. Highly knowledgeable in medical device regulations,

ISO9001/ISO13485, and the Medical Device Directive (MDD) in addition

to submission material for gaining FDA and T V approvals.

Career Background

St. Jude Medical, Cardiac Rhythm Management Division

Manager, Design Assurance (Oct 2000 to Jan 2013)

. Established procedures, processes, and operating policies in the

area Software Verification and Validation. Led process improvement

initiatives for streamlining system definition, risk analysis,

integration, and validation activities.

. Performed internal audit making sure compliance to company

procedures and outside regulatory requirements.

. Contributed in shortening product development life cycle, maximizing

efficiency and productivity of the departments, while supporting the

day to day activities of production and manufacturing.

. Skilled in budget planning, assessment of personnel needs, and

hiring of top notch human resources for the department. Established

and structured programs in training of personnel, and updating them

with the latest tools to maximize productivity of the department.

. Head of Design Assurance to support implementation of automated

manufacturing and other business related systems.

. Six Sigma Champion and Green Belt certified with extensive knowledge

of DFSS and Lean methodologies.

. Group leader for integration of acquired entities. Direct

involvement with Global Contract Manufacturers in India, China,

Malaysia, Sweden, and Puerto Rico.

Siemens Pacesetter

Manager, Software Quality Assurance (Oct 1993 to Oct 2000)

. Responsible for the validation, control, and distribution of class

III medical product software (implantable Pacemakers, and

implantable defibrillator), and all manufacturing test software.

. Developed, documented, and implemented improved software validation

processes and documentation system in accordance with the FDA

guidelines.

. Set guidelines for development of Requirements Specification, Design

Specification, Issue Tracking, and Configuration Management.

. Established an audit program for QA department on off-the-shelf

software or custom software developed by third party.

. Developed a corporate wide software development policy to shorten

the development life cycle and streamline the validation activities.

. Implemented automated software test systems to improve the testing

capabilities and shorten the test time.

Pacesetter Inc

Sr. Software Quality Assurance Engineer (Mar 1989 to Oct 1993)

. Responsible for validation of automated test software utilized in in-

process and final testing of cardiac pacemakers and its components

such as LSIs and Hybrid assemblies.

. Review of software requirement specification, design specification,

and code walk-through.

. Developed Software Validation Plans (SVP) based on requirement

specification. Designed test cases for each requirement in the SVP

with inclusion of specific test procedures and acceptance criteria.

. Performed extensive static and dynamic testing and developed

Software Validation Reports (SVR) to report the results of the

testing.

. Evaluated changes to the software to determine validation activity

against the changes such as limited validation or regression

testing.

. Performed Software risk and hazard analysis to determine criticality

of certain modules.

. Utilized issue-tracking system such as DCS, to report software

issues and assuring that corrective action gets in place to resolve

issues.

ATE Engineer

. Responsible for developing automated test systems for testing

pacemaker products and components such as LSI and hybrid assemblies

using various types of test stations.

. Designed test fixture for interfacing purposes.

. Trouble shooting test station and deploying test system to vendors

supplying components

Minimed Technologies

Sylmar, Ca

Test Engineer

. Responsible for testing of implantable and external drug pump.

. Performed fault isolation activities for assemblies in WIP.

. Trouble shooting assemblies to the component level, generated

reports and recommended corrective action for product improvement

Education & Training

. CALIFORNIA STATE UNIVERSITY, FRESNO, BS Electrical Engineering

. Management in Manufacturing - UCLA

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