Purpose of Position:

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:

Essential Functions:

• 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:
  1. Writing Master Validation Plans and Reports
  2. Process FMEA development and ongoing monitoring
  3. Equipment Installation qualification (IQ) and operational qualification (OQ)
  4. Write and run test method validation studies as applicable
  5. Process operational qualification and process qualification for special processes
  6. Product performance qualification protocols, data analysis, and report
• 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
• 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
• Work to identify and implement targets for Lean Six Sigma improvement
• 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:
  1. RMA receipt, authorization and product return for evaluation
  2. MRR/ NCMR to contain returned items and work in process
  3. Complaint investigations, root cause, containment, and correction
  4. 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 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
• Develop standard quality inspection procedures and
• Promote a culture of compliance with company

Required Experience, Knowledge, Skills, Abilities or Education:

• Two or more years of experience in quality
• BS degree in science, engineering, or
• Demonstrated understanding in quality concepts, practices and
• Strong interpersonal skills are
• 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
• Ability to travel as