Quality Engineer Supplier

NITHISH BHARADWAJ THOTAPALLY Email Id : *******************@*****.***

Phone: +1-248-***-****

SUMMARY:

Quality/Supplier Quality Engineer with 6 Plus years of experience in Quality Systems, Statistical Analysis, Six Sigma, Lean Manufacturing, Project Management.

Assisted Client facilities in mitigating systemic supplier quality non-conformance issues by driving to root cause and working with suppliers to implement corrective actions, generate supplier scorecards for top suppliers and provide feedback to suppliers and internal customers.

Working Knowledge of DOE and SPC methods using Minitab, Control charts Cp/Cpk, BOM.

Working Knowledge of quality system methodologies, fish bone diagram, 5 Why’s, PFMEA, DFMEA, Pareto Analysis.

Strong knowledge and experience of FDA 21 CFR part 820 regulations, ISO 13485, and ISO 14971 standards for Medical Devices.

Knowledge of Six sigma tools (5S, Kaizen, 5Whys, Root Cause Analysis etc.), Lean Manufacturing and Statistical Analysis and 7 Quality tools and Risk assessment.

Experienced in IQ, OQ, PQ, Gage R&R, Test Method Validation and CGDP’s.

Work Experience:

Edwards Life Sciences Draper, UT Sr Quality Engineer March 2024 to Present

Interpreted drawings, product/performance specifications, and other systems integration technical data.

Developed and maintained sampling methods and procedures for inspections, testing and evaluation.

Worked with product / process transfer projects to ensure compliance with the procedures, as well as the facilitation of the activities required in the transfers.

Reviewed and approved feasibility studies, process / product changes, technical reports, product transfers, market and clinical trial plans, and protocol reports.

Performed TMV’s and capability and PQTM activities.

Responsible for developing incoming inspection and First Article Inspection (FAI) documents.

Viant Medical Fremont, CA

Sr Quality Engineer January 2022-January 2024

Supported regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.

Interpreted drawings, product/performance specifications, and other systems integration technical data.

Interfaced with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable.

Developed various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures.

Monitored daily production runs, performing in-process inspections of injection molded components to ensure conformance to drawings and specifications.

Lead and managed complaint investigations and remediation recommendations as needed.

Lead plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.

Philips Medsize Hudson, WI Quality Engineer September 2021-January 2022

Managed the Supplier qualification process; lead corrective actions relating to supplier performance and improved process for supplier data submission to reduce internal inspections.

Lead the investigation of out of specification situations to determine if there is impact to released product. Wrote technical reports in support of NCMR investigations, CAPAs and containment activities used to support recall or no recall decisions.

Interfaced with engineering, operations, customer, and vendor representatives to ensure all requirements are met.

Responsible for leading change control teams to ensure changes to processes and equipment do not impact product quality or the validated state.

Facilitated communication between engineering function, manufacturing, and quality.

Becton Dickinson Covington, GA &Sparks, MD

Quality Engineer July 2017-September 2021

Facilitated communication between engineering function, manufacturing, and quality.

Facilitated root cause analysis and corrective actions of supplier quality issues.

Reviewed supplier manufacturing processes collaborate with suppliers on process improvement and value enhancement opportunities.

Generate quality alerts for product returns, warranties, recalls or internal defects.

Performed complaint investigations for all BMD and OEM manufactured products.

Facilitate root cause analysis and corrective actions of supplier quality issues

Maintained a working knowledge of BMD policies and procedures and ISO and FDA requirements.

Skills:

Software Tools: Minitab, Track wise, MS Office, IQMS.

Lean Manufacturing Tools: 5S, Kaizen, JIT, SMED. PDCA, Time Study and Work study.

EDUCATION QUALIFICATION:

Master’s in engineering management- University of Detroit Mercy- Detroit, MI 2017

B-Tech in Mechanical Engineering from JNTU University, Hyderabad, India 2014.

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