Subramaniam Krishnan

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Senior Quality Engineer

Subbu has more than 11 years of hands-on engineering experience in manufacturing and operations for the biotech and medical device industries.  He has 25 years of leadership and change management expertise in manufacturing and operations based on engineering fundamentals of Six Sigma, lean management, project management, risk management, statistical process validation, Kaizen and Total Quality Management (TQM).  Subbu has a solid  track record of significant contributions towards core metrics and balance score cards through continuous process and quality improvement, cost reduction, efficiency, service & productivity improvement and technology upgrades through a number of problem solving and DMAIC Projects. He is a veteran of more than 500 Validations (EQ/TFIQ, IQ, OQ,PQ, PPQ and TMV), 50 FMEAs, 500 Non-conformances (NCR/MRB/SCAR), 100 CAPAs and 50 Lean Six Sigma improvement projects.


  • Experienced with precision casting, molding (injection and dip coating) and extrusion operations, stamping, machining and surface treatment (ferrous and non-ferrous metals), packaging lines, guide wire hydrophilic dip coating operations, water systems, cleaning and assembly lines for catheters, endoscopy and peripheral vascular devices.
  • Provided support for internal and external audits for quality and safety as subject matter expert (SME).
  • Provided remediation and Inspection Readiness support for FDA 483, Warning Letter and Consent Decree.
  • Executed diverse process validations (IQ,OQ, PQ & PPQ and TMV), equipment, utilities and facility validations including generation of protocols/reports and deviation/discrepancy resolution.
  • Proficient in the use of statistical software such as Minitab, Change Point Analyzer and Vartran in addition to proficiency with Microsoft Excel, MS Project Pro and Visio.
  • Experienced with identification and implementation of manufacturing improvements utilizing techniques from Six Sigma (DMAIC, Variation Reduction, DOE, Robust Tolerance and Mistake Proofing), Lean (5S and Kaizen) and Statistical Process Validation (IQ, OQ, PQ & PPQ and TMV) for increasing efficiency, throughput & process simplification and technology replacement.
  • Conducted Design Validation/Verification, Design Control, Process Control, Risk Analysis (HA and PFMEA/DFMEA/AFMEA).
  • Knowledge of quality and regulatory standards (cGMP, ISO 13485, ISO 14971, QSR and 21 CFR 820).
  • Managed and mentored a team of 20 Engineers working on the Measurement System Analysis (MSA) and GD&T project for a leading orthopedic implants manufacturer. Successfully completed training, orientation and adaptation of the project team to the client’s operations system and completed the project ahead of schedule.
  • Collaborated on a strategic initiative for implementation of Six Sigma Program for CAPAs, Lean Manufacturing and Continuous Improvement.
  • Resolved customer complaints in collaboration with sales team and initiating quality improvement projects (raw material change and design change).
  • Experienced with continuous process improvement work including prototype improvement, alternate materials for cost efficiency and improve quality and throughput, thereby increasing yield and reducing customer complaints.
  • Modified processes on the critical path of production to improve throughput by 100%.
  • Employed time and motion study to modify the work shift sequence of operations thereby reducing idle times in the process and helped in reducing labor hours.
  • Implemented process development work for evaluation of new materials, processes and technology for quality improvement and cost reduction. Headed the TQM group and was the team leader for implementation of Kaizen events.
  • Senior Quality Engineer – BioTeknica, Inc.
  • Quality Engineer – Goode Consulting
  • Principal Manufacturing Engineer – Boston Scientific
  • Production Manager – Omega Casting
  • Operations Manager – Loren Industries
  • Production Engineer – Shrenuj & Co. Ltd.
  • M.B.A. – Florida International University
  • B.S., Electronics Engineering – University of Bombay
  • American Society For Quality (Certified Six Sigma Black Belt – Senior Member)
  • Society of Manufacturing Engineers (SME)
  • Florida Engineering Society (FES)