Designation: Quality Engineer
Qualification: Bachelor’s Degree
- Responsible for inventory requisition and conduct product inspections. Perform gauge
inspection for the affected lot and prepare manufacturing process forms with the
- 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
- 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)
- 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
- 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
- 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
- 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
- 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.