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Quality Engineer

Zeus Company, Inc.
San Jose, CA Full Time
POSTED ON 2/19/2025
AVAILABLE BEFORE 5/19/2025

Job Description

Job Summary

The Sustaining Quality Engineer (QE) works as an integral part of the CathX Medical engineering team responsible for developing and supporting the processes and production of high-quality medical products. The QE is a voice of quality in obtaining customer requirements, new product transfer to manufacturing, manufacturing readiness. They are a driving force to investigate, contain, and resolve customer quality issues and other day to day production issues. Responsible to provide Quality Engineering support across Transfer to manufacturing and Sustaining production operations business lines as detailed below :

Responsibilities

  • Monitor quality and process metrics to evaluate process and product performance, define inspection and testing methods and requirements, and work with other engineering and manufacturing staff to ensure that customer requirements are met.
  • Support process validation testing for manufacturing readiness projects to improve CathX Medical capabilities and yield. Support development and execution of Process Validations, including the following elements :

Writing Master Validation Plans and Reports

  • Process FMEA development and ongoing monitoring
  • Equipment Installation qualification (IQ) and operational qualification (OQ)
  • Write and run test method validation studies as applicable
  • Process operational qualification and process qualification for special processes
  • Product performance qualification protocols, data analysis, and report generation.
  • Resolve any special customer requirements regarding quality assurance methods and sampling, testing, and certification requirements in cooperation with engineering and to ensure agreement between CathX Medical documents and records and Customer drawings and specifications.
  • Draft and execute design of experiments (DOE)and capability studies to optimize processes or resolve problems.
  • Work as a part of a core team with Development and Manufacturing Engineering as required in transfer projects and manufacturing readiness builds.
  • Contribute to all transfer project deliverables, including Design and Process FMEA, master validation plans, first article inspections, supplier qualification, and control plan development.
  • Support the development of and critically review RM, MM, SA, LHR, MPI, In- process inspection plans, and related specifications for the projects and products you support through the engineering change order and deviation processes.
  • Create or review receiving and final inspection plans for components and assembly.
  • Work to identify and implement targets for Lean Six Sigma improvement projects.
  • Work with Engineering and Operations in the day-to-day identification& resolution of production issues.
  • Communicate with customers and perform or manage the process for the following activities / systems :
  • RMA receipt, authorization and product return for evaluation

  • MRR / NCMR to contain returned items and work in process
  • Complaint investigations, root cause, containment, and correction
  • CAPA for occurrence prevention, occurrence detection, and systemic resolution
  • Support the review of LHR and product release through generation of certificates of compliance.
  • Assist inspectors and technicians by providing expert input on whether products are within or out of specification. Update MPI with images of good and bad parts as the issues are detected. Implement visual standards as agreed with Engineering and Operations.
  • Perform internal audits and support external audits as requested by quality management.
  • Develop standard quality inspection procedures and methods.
  • Promote a culture of compliance with company procedures.
  • Qualifications

  • Two or more years of experience in quality engineering.
  • BS degree in science, engineering, or manufacturing.
  • Demonstrated understanding in quality concepts, practices and procedures.
  • Strong interpersonal skills are required.
  • Ability to plan, establish and coordinate test and inspection procedures, conduct process capability studies, prepare statistical quality control data and develop statistical designed experiments.
  • Knowledge of FDA 21 CFR Part 820 or 13485.
  • About Us

    Zeus Industrial Products, headquartered in Orangeburg, South Carolina, is the world's leading polymer extrusion manufacturer and material science innovator. More than 50 years of experience in medical, aerospace, energy, automotive, fiber optics, and more allows us to set the bar high.

    Zeus is a great place to work. Expectations are high; our work is meticulous and very precise. Zeus offers an opportunity to join a very successful, family-oriented team. Our products are cutting-edge, our process is unique, and our quality and customer focus are second-to-none. We are a leader in our field and have great relationships with our customers and team members. Many of our team members are the best at what they do in the world. Our customers are leaders in their fields. Our products help save lives.

    Continuous Improvement is a way of life at Zeus. Successful candidates will have a desire and ability to take our manufacturing process to the next level. Expectations are high; our work is meticulous and very precise. You must possess the ability to work independently; and the desire to learn a variety of skills. The ability to communicate clearly is imperative, as is the ability to manipulate data using various software packages.

    At Zeus, what we do matters, and we pride ourselves in "Turning polymers into possibilities." Expectations are high; our products are cutting-edge, our process is unique, and our quality and customer focus are second-to-none.

    Our employees and our customers are at the center of everything we do. Those relationships have been built on a foundation that is supported by our Mission and Vision :

    Our Mission : Provide Solutions - Enable Innovation - Enhance Lives

    Our Vision : Working Together - Doing It Better

    Zeus is an exciting, innovative company that offers competitive pay and a great benefits package. As we continue to push the boundaries of polymer science, we're constantly in need of new ideas, new expertise, and new team members. Are you ready to join us?

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