RIDDHI PAREKH

Email: adcito@r.postjobfree.com, Phone: +1-469-***-****, LinkedIn: https://www.linkedin.com/in/riddhi- parekh/

OBJECTIVE

Seeking full time opportunities in Quality Engineering/ Regulatory Engineer/ Mechanical Engineering in Medical Device Industry with Knowledge of FDA and ISO Standards. EDUCATION

The University of Houston, Texas

M.S., Biomedical Engineering

May 2019

3.69/4

Coursework: Medical Device Regulation and Regulatory Strategy Biomedical Image processing Quality Assurance Biomedical Signal Processing Neural Networks Statistical Analysis in Biomedical Biostatistics U.V. Patel College of Engineering, Gujarat, India

B.Tech., Biomedical and Instrumentation Engineering May 2016

8.67/10

SKILLS:

ISO 14971, ISO 13485, ISO 9001, 21 CFR Part 820, Medical Device Standards, Corrective and Preventive Action CAPAs, FDA, Validation, FMEA, GMP, GD&T, Gage R&R, GMP. Tools: MS Office, MATLAB, Agile PLM, MINITAB, JMP 13 Statistical Software, Solidworks. PROJECTS:

Lean Six sigma green belt project Jan 2019-May 2019

Identified root cause issues and applied Lean and Six Sigma methodology by going through all 5 phases and improved the methodology like DOE data Analysis, FMEA, FTA, PDPCs, etc. by 12% and prepare reports on it.

Applied statistical analysis in JMP 13 like correlation, Regression or t-test and directed 5S, Lean SS, SPC, DMIAC Kaizen, and Lean initiatives and sampling principals and risk analysis that increased profit by 8%. Regulatory Strategy for Innovative Device Aug 2017-Dec 2017

Understanding, analyzing, and interpreting requirements from diverse regulatory environments throughout the product development lifecycle for US and preparing 510(k) for new/modified instrument.

Used regulatory strategies like CE approval, EU Medical Device Directive, FDA 510(k) pathway, QMS compliance with ISO 13485, preclinical & clinical evaluation and utilized ISO standards.

Testing all standards required depending on the class of Instrument for approval of the device in other nations after approval in USA with applied GMP.

EXPERIENCE:

Manufacturing Engineer

Zimmer Biomet Spine, Colorado, USA July 2019 - Current

Working within a UDI project for EU MDR, reviewing and approving design and development documents including 2D and 3D drawings, Inspection Protocol Record, IP, IIDR, SCP, IPR and other Quality documents.

Review design drawings and make sure that final drawing is in line with MDR requirements.

Contacting Suppliers for Supplier control plan inquiries and SPPA. The purpose of SPPA is to provide evidence that the supplier’s manufacturing equipment, tooling, and process will produce product consistently meeting design requirements during production.

Reading prints by paying very close attention to the Geometric Dimensioning and Tolerance (GD&T) of various different products of in-vitro instruments related to spine and choosing the right tolerances to add laser markings and assuring compliance to internal and external specifications and standards (i.e. GMP, ISO, FDA, MDD) and establishing Bill of Material (BOM) and inspection protocol records (IPRs) with correct Notified body and also correct Inspection method (i.e. Visual, VMM, CMM, Comparator, Pin Gage, Height Gage, other attribute and Variable instruments)and correct Sample plan with appropriate AQL level for Supplier as well as Zimmer Inspection.

Supporting a wide variety of processing applications such as precision machining, finishing, grinding, forging, casting, product cleaning and sterilization, heat treating, bonding, molding, etc. according to ISO 13485 quality standards.

Improving process methods which meet performance and quality requirements. Creating MCOs and ECOs on Agile and approving stuff online from a Manufacturing Point of view.

Performing Gage R&R on Variable and Attribute Measuring Gadgets in MINITAB or JMP 13 Statistical Software with large data sets and wrote WI’s for the same. Graduate Assistant

University of Houston, Texas, USA Jan 2018 – Feb 2019

Co-ordinated and led a team of 7 people to work in an orderly manner that can reduce wait time.

Focused on continuous improvement by reducing wastage of inventory using a 5s technique. Quality Control Intern

Techno Medico Services, Vadodara, India Oct 2016 - Jan 2017

Analyzed and solved recurring issues in device failure by executing corrective strategies after conducting root cause analysis thus reduces the failure mode by 3% and maintained quality compliance. Performed Regression or correlation analysis and t-test to analyze the problem and Design Control.

Analyzed variability in the production inspection techniques using Gage R&R and proposing solutions by plotting ANOVA plots and DMIAC.

Performed process improvement activities using six-sigma techniques; process validation like IQ, OQ, PQ. Summer Intern

Sterling Hospital, Vadodara, India June 2015- July 2015

Gained theoretical as well as practical knowledge of medical devices, maintenance and repair techniques.

Performed preventive maintenance, basic configuration and techniques for troubleshooting medical devices. CERTIFICATION

Six Sigma Green Belt, University of Houston, Texas