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
- 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.
• University Of Southern California Masters in Biomedical Engineering.
• V.E.S. Institute of Technology, Mumbai Bachelors in Instrumentation Engineering.
• V.E.S. Polytechnic, Mumbai Diploma in Instrumentation Engineering.
• 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.
• 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