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Detail driven engineer with 3+ years of experience, proven background in achieving assigned engineering project goals. Detail oriented expertise in product development, quality assurance, process improvement, quality management system, ISO implementation and standards, corrective preventive action, supplier/vendor management. Experienced at streamlining processes to improve productivity, Demonstrated knowledge of Solidworks and Minitab


CAPA, FMEA, Quality engineer GMP, FDA regulations, APQP, Six Sigma, Lean Manufacturing, process improvement, Data and trend analysis, Quality Assurance, Process/Product audit, ISO 9001 Implementation and document management, continuous improvement, customer/supplier interfacing, Process streamlining, Non conformance study, Statistical process control (SPC), Design of Experiments (DOE), Capability study, GD&T, Inspection Procedures,Quality Function Deployment (QFD, Solidworks.

Work experience

Jun 2010Present

Quality Engineer

Nuvasive Medical Devices

Working in coordination with Quality Compliance (ISO 13485, 21 CFR 820, and FDA) department to review non conformances of Spinal Implants and surgical instruments. Involved in various functionalities of calibration, functional testing (Data recording through SAP)and Material Review Board (For CAPA and SCR’s) for medical devices such as implants and instruments Demonstrated applied knowledge of: International medical device and FDA regulations; Monitoring root cause and investigations and CAPA (through vendor follow up)are performed in timely manner as documented in Non Conforming Material Report (NCMR)

Demonstrated applied knowledge of: International medical device and FDA regulations;

Aug 2007May 2010

Lab Assistant

Rochester Institute of Technology

Working as a lab and teaching assistant for Geometric Dimensioning and tolerancing (GD&T) • Troubleshooting for all equipment malfunctions with attention to details • Problem solving through excellent customer service and strong communication skills • Experience using computer software & hardware; both PC & Macintosh • Enforcing all lab policies • Responsible for security access and alarm panel codes

Jan 2009Mar 2009

Quality Management Co-op

RPC Photonics

•Achieved internal ISO 9001 compliance and document structure within target period, procedures and work instructions, through out the processes determining total number of operations and corresponding documentation

  •  Supported the program manager to implement the ISO 9001 quality management system (QMS)
  •  Standardized work instructions throughout the production area
  •  Major contributor in creating the documentation and control structure within the company
  • Prepared schedule and assignments to achieve an ISO compliant quality management system in second quarter of 2009
Jun 2008Dec 2008

Co-op, (Manufacturing and Process Technology)

Sanofi- Pasteur Inc., Swiftwater, PA

Implemented new product flow line, complying with FDA and cGMP regulations, to modify manufacturing set up that resulted in cost saving through removal of frequent tubing replacement.

  • Worked on troubleshooting of equipments such as Sterimixer by performing detailed parts and operations evaluation (root cause analysis based on CAPA Methodology) complying with FDA regulated Standard operating procedures (SOP), Standard work instructions (SWI) and protocols
  • Executed equipment Installation Qualification (IQ) and Operational Qualification (OQ) validation protocol
  • Interfaced with suppliers and vendors for quotations, repair and replacement of equipments including check valves, impellers etc. and new equipment procurement
Jul 2003Sep 2005

Quality- Manufacturing Process Engineer


Minimized waste/scrap utilizing lean manufacturing through identification of process improvement opportunities, which resulted in 25-30% cost saving Led a team of supervisors and technicians for process optimization, through QIT (Quality Improvement Team), which effected in an increment of production capacity by 25% (25 to 32 parts per day) involving (Work Station auditing) New Product Development Initialized and developed the idea of new product design and development, using SOLIDWORKS, for a load equalizer starting, saving material and 35% production cost,

  •  Implemented Lean Manufacturing based production system.
  •  Scheduled production planning, inspected performance analysis of the production line and measured critical parameters of the product to report non-conformance.
  •  Assisted in designing and implementing Manufacturing processes for new product
  •  Performed Process Capability analysis (CpK), analyzed data using control charts
  •   Conducted process, product audits, and vendor audits
  •   Performed Root cause analysis and Corrective Action resulting in the permanent removal of the fundamental problem and improved the customer index.
  • Maintained and reviewed Manufacturing drawings for Change Control(PPAP)
  • Maintained inspection procedures, quality assurance plans, test procedures and process flow documentation to ensure ISO compliance.


Richard Andrejko

Paul Mclaughlin

Judy Winn





North Maharashtra University


Rochester Institute of Technology