Quality Assurance Inspector

Full Time
Ponce Municipio, PR
Posted
Job description

Requisition Number

AMER27281

Employment Type

Full-time

Location

Ponce
Job Summary

Zimmer Biomet is a global medical technology leader. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.


To inspect thermoformed cavities and lid stocks (Tyvek® / Mylar) peel pouches sealed with 100% accuracy of Continuous Process Monitoring procedures. Document Sterile Process CPM Testing Day Release Form once all CPM results are gathered for all specific product types. Assure Product Final Cleaning Monitoring Program.

Principal Duties and Responsibilities
  • Trained in current revision of CPM procedures.
  • Verify before performing CPM test that equipment is currently calibrated.
  • Perform Gross Leak Test, Seal Visual Inspection, Seal Strength and Creep Test following applicable procedures. • Perform sample testing and document the results.
  • Visually evaluate packaging seals.
  • Perform Tensile Test Using Instron Peel Tester Machine.
  • Detecting Gross Leaks in Medical Device Packaging by Internal Pressurization.
  • Perform Burst and/or Creep testing using the TM-Electronics, BT Integra-pack.
  • Assure Product Final Cleaning Monitoring Program.
  • Document in Continuous Process Monitoring Samples Pick-up Log.
  • Document in Continuous Process Monitoring Cage Log of thermoformed cavities and lid stocks (Tyvek® / Mylar) peel pouches sealed.
  • Assure the thermoformed cavities and lid stocks (Tyvek® / Mylar) peel pouches sealed samples are conditioned in the time and environmental conditions required.
  • Collect PMMA form, also Nitrogen Packaging Altitude and Oxygen Test Log generated by manufacturing personal.
  • Inform in a monthly basis scrapped pieces for Final Cleaning monitoring program.
  • Must follow environmental requirements of the position. This includes clean room conditions of which gowns and caps are required.
  • Comply with all Company Safety Requirements.
  • Collect samples from the passivation area and deliver to the laboratory correspond to the Monitoring program of passivation.
  • Continuous process monitoring program at incoming inspection, pickup samples from “Beijing” & “Changzhou” them take to the laboratory for testing
  • Provide required documentation for the final release process of manufactured product.
  • Performs other tasks within the work area, as instructed by the Supervisor or Designee.
Expected Areas of Competence
  • Strong knowledge of CPM procedures. Knowledge of CPM equipment, (i.e.Instron Machine, BT Integra Pack, Gross Leak test system, Visual Aids, etc) and capable of performing minor maintenance as required.
  • Perform CPM inspections with 100% accuracy.
  • Basic knowledge of computer.
  • Must be able to work under pressure and meet deadlines. Must be detail oriented.
  • Team work and customer focus oriented. Good interpersonal relationship skills.
Education/Experience Requirements
  • High School Diploma required.
  • Experience in a manufacturing environment preferred.
  • Clean room environment experience preferred.
Travel Requirements

5%

Additional Information

At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.


As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. This is why we offer you a competitive rewards package that includes medical, dental, vision, life and disability insurance, wellness incentives, employee assistance programs as well as paid time off for vacation and holidays.


EOE/M/F/Vet/Disability

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