Description

• Responsible for inventory requisition and conduct product inspections. Perform gauge
  inspection for the affected lot and prepare manufacturing process forms with the
  inspection results.
• Responsible for performing stock investigation and performing inspection activities.
• Responsible for requesting inventory of Biomet Affixus Nails as part of Product hold
  inspection. Recorded the inspection data through Manufacturing Process Forms (MPF)
  and released conforming parts.
• Perform Inspection on receiving First Article Samples (FAS) Parts with Best Fit gage pin.
• Responsible for Phoenix Nail inspection as a part of complaint triggered hold.
• Phoenix Trochanteric Nails will be inspected on a comparator for bend angle inspection.
• Report data through First Article Investigational Layouts and analyze data in comparison
  to actual print dimension.
• Phoenix Tibial Nails will be inspected for critical to Quality (CtQ) features on Coordinate
  Measuring Machine (CMM). Report data through First Article Investigational Layouts
  and analyze data in comparison to actual print dimension.
• Responsible for assuring products conform to established requirements and standards
  through appropriate audit, inspection, and test activities.
• Responsible for monitoring manufacturing technicians and ensuring production process
  for the current Work Instructions.
• Responsible for documenting Health Hazard and Issue evaluations on a regular basis for
  non-conforming products as part of continuous improvement.
• Perform evaluations and provide weekly updates on Health Hazard Evaluations and Issue
  Evaluations.
• Develop Receiving inspection criteria and sample plans with justification.
• Create/update Qcriteria and Icriteria for NPI projects and existing products.
• Responsible for reviewing prints. Identify critical personnel, gauges, procedures, and
  materials needed for the completion of new products.
• Review new launch bubble prints with basic knowledge in print reading. Verify for
  feature numbers, measurements, units, tolerance and format.
• Identify Critical to Quality features for Flush End caps, Tibial Nails, Retrograde Nails,
  Bone Screws, Cortical Nuts in Affixus Family as part of new product launch.
• Create Gauge overlays to inspect screw head and thread profile. Create Gage Usage
  Procedures (GUP) as needed.
• Generated First article layouts (FAL) for Medical Devices. Create FAL for ALPS
  Clavicle plates, Drill Guides, Soft Tissue Guides, Soft Tissue Handle, Depth gauge and
  many other implants & instruments which are part of New Product Introduction (NPI)
  projects.
• Collect and analyze data for gauge and product evaluation. Define critical features for
  inspection method and sample size.
• Assisted in supplier product testing. Worked with suppliers to get quality products on
  time.
• Review/ approve PPAP+ documents from vendors (defining requirements for qualifying
  production process with vendors).
• Identify the objective evidence requirements to support investigation and root cause
  conclusions. Identification of root cause and investigation results will be documented.
• Determine root cause and made corrective action recommendations as problems occur.
• Responsible for investigation of released product non-conformances (NCR’s), trend
  trigger events, and health hazard analysis in collaboration with other functions. Provide
  Quality record search analysis (QRSA) forms with the search parameters, methods and
  results on value-added trend data.
• Responsible to review Package inserts and PFMEA risk documents for risk assessments
  as part of design control risk management.
• Performed Health Hazard evaluations for Zimmer Natural Nails for BSI Tech File Audit
  Findings on missing evaluations of Magnetic Resonance Environments and risk of reuse
  in Package Inserts.
• Performed Evaluations for BSI Audit Findings on Dynafix VS Osteotomy System on
  missing MR Evaluations and Cleaning Validations.
•  Reviewed Design Failure Mode effect analysis (DFMEA) for Zimmer Plates and Screws.
• Updated new risk lines and formatted for appropriate procedure change. Provided
  rationale Memo for the changes made and routed the changes through change
  management system (CMS).
• Responsible for ensuring compliance with all appropriate procedures, establishing the
  inspection plan and methods for ensuring conformance to specifications.
• Responsible for evaluating corrective action and preventive action (CAPA) Records for completeness and accuracy. Perform Complaint–out-of-box (COOB) analysis, in search of affected lot.
• Collaborates with engineering and manufacturing functions to ensure quality standards
  are in place. Responsible for documenting Technical protocols and technical reports.
  Perform gage R&R, capability study and Attribute/Variable sampling plan acceptance
  criteria.
• Perform Unique Device Identification (UDI) Memo forms reviews.
• Perform industry standard capability study in Minitab for the inspection method to be
  acceptable. Released the Nails from hold worth $250,000~. Report the analysis through
  Technical Report.
• Develop cleaning cycle protocol and testing report using FDA Standard worst case
  scenario cleaning parameters.
• Develop sterilization protocol and testing report using FDA standard worst case scenario
  sterilization parameters.
• Complete trainings that are assigned on a weekly basis depending on the assigned work
  and scheduled tasks.
• Complete training forms as a proof of completion.
• Provide updates and feedback on new revisions. Perform tasks per the current training
  procedures and standards.
• Attend Introductory Print Reading and GD&T Training.

Bachelor’s degree: Industrial Engineering or related field.