Pratik Patel

• 1.Dimensional Inspection: Using precision measurement tools (e.g., calipers, micrometers, CMM) to check the outer diameter, inner diameter, thickness, free height (for springs), and other key dimensions, ensuring they are within specified tolerances.
  2. Visual Inspection: Inspecting components for surface defects like cracks, burrs, or deformation and verifying surface finishes and treatments for quality (e.g., corrosion resistance).
  3. Testing: Conducting functional tests on wave springs (e.g., load deflection, spring rate) to verify performance under load. For steel rings, ensuring proper fit (e.g., clearance or interference fit).
  4. Documentation: Recording inspection results in reports, maintaining traceability, and documenting any non-conformance issues.
  5. Compliance: Ensuring products comply with industry standards, customer specifications, and quality control plans before approval for shipment.

- SPC Auditor

1. Dimensional Inspection: Using precision measurement tools (e.g., calipers, micrometers, CMM) to check the outer diameter, inner diameter, thickness, free height (for springs), and other key dimensions, ensuring they are within specified tolerances.
2. Visual Inspection: Inspecting components for surface defects like cracks, burrs, or deformation and verifying surface finishes and treatments for quality (e.g., corrosion resistance).
3. Testing: Conducting functional tests on wave springs (e.g., load deflection, spring rate) to verify performance under load. For steel rings, ensuring proper fit (e.g., clearance or interference fit).
4. Documentation: Recording inspection results in reports, maintaining traceability, and documenting any non-conformance issues.
5. Compliance: Ensuring products comply with industry standards, customer specifications, and quality control plans before approval for shipment.

• Regulatory & Compliance:
  
  
  • ISO 13485: International standard for quality management systems in medical devices
  • ISO 14971: Risk management for medical devices
  • GMP: Good Manufacturing Practice
  Testing & Validation:
  
  • Quality Control (QC): Inspection, testing, and verification of product quality
  • Validation: Process validation, software validation, sterilization validation
  • Verification: Design verification, product verification
  • Risk Analysis: Failure Mode and Effects Analysis (FMEA), Hazard analysis
  • Non-Conformance (NC): Identification of products that don’t meet standards
  • Device Testing: Electrical safety, biocompatibility, mechanical testing, stress testing, sterility testing
  • Cleanroom Standards: ISO class 7, ISO class 8, air quality, particle control
  • Material Compatibility: Biocompatibility, toxicity testing, material degradation

• General Science:
  
  - Scientific Method: Hypothesis, experiment, observation, analysis, conclusion
  - Data Analysis: Variables, control, independent/dependent variables, accuracy, precision
  - Measurement: SI units, metric system, length, mass, volume, time, temperature
• Chemistry:
  
  • Atomic Structure: Atom, protons, neutrons, electrons, periodic table, isotopes, ions
  • Chemical Bonds: Ionic bond, covalent bond, metallic bond, valence electrons, molecule
  • States of Matter: Solid, liquid, gas, plasma, phase changes, melting, boiling, freezing
  • Chemical Reactions: Reactants, products, balanced equations, catalysts, exothermic/endothermic reactions
  • Acids and Bases: pH scale, neutralization, strong/weak acids, bases, indicators
  
  Physics:
  
  • Motion: Velocity, acceleration, speed, displacement, force, Newton’s laws, inertia
  • Energy: Kinetic energy, potential energy, conservation of energy, work, power
  • Waves: Frequency, wavelength, amplitude, sound, light, electromagnetic spectrum
  • Electricity: Current, voltage, resistance, circuits, Ohm’s Law, charge
  • Thermodynamics: Heat, temperature, entropy, conduction, convection, radiation