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Quality Assurance Engineer

Lake Forest, CA
April 30, 2014

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Sahil Ahuja


Quality Assurance Analyst, Tekia INC. (Intra-ocular Lens Manufacturer) California July 2012 - Present

• Planning, scheduling and conducting Internal Audits of entire QMS per ISO 13485, MDD & 21CFR 820.

• Investigating and documenting Non-Conformances based on root cause analysis. Performing

risk-analysis and implementing a corrective and preventive action plan (CAPA).

• Developing, writing, updating test methods & operating procedures to facilitate continuous conformity.

• Managing the calibration, maintenance and environmental monitoring program, ensuring facility and

equipments remain are in specification & complaint with external standards & internal procedures.

• Preparing validation protocols and performing validations (IQ, OQ, PQ) of manufacturing processes,

equipments and Software (ERP, labeling database).

• Reviewing incoming material and related documents to ascertain compliance with specifications and

authorizing the compliant material's release to production.

• Certifying the final shipped product after assuring compliance with release criteria & specifications.

• Analyzing new & revised standards for their impact on Quality System to ensure continued compliance.

• Representing firm in external audits (Notified body, FDA, KFDA) for areas under my responsibility.

• Systematically analyzing and summarizing the progress of the ongoing projects, quality objectives and

goals set in the QIP (Quality Improvement Plan) for management reviews.

• For implementation of the ERP system integrated with JOB-OPS:

- Created precise operation based raw material and finished goods inventory tracking with detailed

reports for better management of resources and production planning.

- Developed custom configurations for each manufactured model to streamline data entry during

manufacturing process.

- Designed minimalistic paperless work orders reducing user input accounting for increased

efficiency on the production floor and better documentation control.

Quality Engineer, Vishaltech Engineers, Mumbai June 2009 - August 2009

• Testing and troubleshooting of electronic measurement devices and equipment helped me develop and

enhance my problem solving skills.

• Performed calibration and testing of gauges, transmitters, and pneumatic/hydraulic control valves.

• Developing and documenting standard operating procedure for calibration processes.

• Entrusted with documenting and preparing quotations and detailed reports of service provided.


May 2012

• University Of Southern California Masters in Biomedical Engineering.

July 2010

• V.E.S. Institute of Technology, Mumbai Bachelors in Instrumentation Engineering.

July 2007

• V.E.S. Polytechnic, Mumbai Diploma in Instrumentation Engineering.

Academic Projects

• Prepared & documented an abbreviated 510k Submission for Class II Transcutaneous Nerve simulator.

• Developed a Labview simulation with an Autocad model of an automated batch reactor with pressure

and level control loops for safety to be used in a manufacturing process.

• Designed & developed a burglar alarm system, which triggered due to changes in temperature, light

intensity & pressure.

• Led a team to create a working model of a “Pre-physicians chair” fully equipped with sensors to enable

measurements of essential body parameters before actual checkup.

Technical Skills

• Software: AutoCad, Solid Works. Labview, Simulink, Matlab, Mini-tab, Crystal Reports, ERP Mass 90.

MS office applications, MS Project, MS Visio, Windows and Mac Operating systems.

• Standards: ISO 13485, ISO 14971, ISO 9001, ISO 17025, 11979 series, HIBC ANSI Labeling Standard.

• FDA & EU regulations: 21CFR 820, 21CFR 801, 21CFR 803. Medical device directives, Canadian MDR.

Cell: + 1 Email: S a hi l .a @me. com


( 94 9 ) 2 87 2 817

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