Quality Assurance Engineer

1 week ago

Sunnyvale, California, United States CathX Medical Full time
Job Overview

The Sustaining Quality Engineer plays a crucial role within the CathX Medical engineering team, focusing on the development and support of processes that ensure the production of high-quality medical devices. This position serves as a key advocate for quality, ensuring that customer specifications are met, facilitating the transition of new products to manufacturing, and preparing for operational readiness.


Key Responsibilities:
  • Evaluate quality and process metrics to assess product and process performance, establish inspection and testing protocols, and collaborate with engineering and manufacturing teams to fulfill customer expectations.
  • Assist in process validation testing for manufacturing readiness initiatives aimed at enhancing CathX Medical's capabilities and yield. Responsibilities include:
    1. Creating Master Validation Plans and Reports
    2. Developing and monitoring Process FMEAs
    3. Conducting Equipment Installation Qualification (IQ) and Operational Qualification (OQ)
    4. Executing test method validation studies as necessary
    5. Performing process operational qualification and qualification for specialized processes
    6. Creating product performance qualification protocols, analyzing data, and generating reports
  • Address unique customer quality assurance requirements regarding sampling, testing, and certification in collaboration with engineering to ensure alignment between CathX Medical documentation and customer specifications.
  • Design and implement experiments (DOE) and capability studies to enhance processes or troubleshoot issues.
  • Collaborate with Development and Manufacturing Engineering teams on transfer projects and operational readiness.
  • Contribute to all deliverables related to transfer projects, including Design and Process FMEAs, master validation plans, first article inspections, supplier qualifications, and control plan development.
  • Support the formulation and critical review of RM, MM, SA, LHR, MPI, and in-process inspection plans for projects and products through engineering change orders and deviation processes.
  • Create or evaluate receiving and final inspection plans for components.
  • Identify and implement targets for Lean Six Sigma improvements.
  • Work alongside Engineering and Operations to identify and resolve daily production challenges.
  • Engage with customers and manage processes related to:
    1. RMA receipt, authorization, and product return for evaluation
    2. MRR/NCMR to manage returned items and work in progress
    3. Complaint investigations, including root cause analysis, containment, and corrective actions
    4. CAPA for prevention, detection, and systemic resolution of occurrences
  • Assist in the review of LHR and product release through the generation of certificates of compliance.
  • Provide expert guidance to inspectors and technicians regarding product compliance and update MPI with images of compliant and non-compliant parts as issues arise. Implement visual standards in collaboration with Engineering and Operations.
  • Conduct internal audits and support external audits as requested by quality management.
  • Develop standard quality inspection procedures.
  • Foster a culture of compliance within the organization.
Qualifications:
  • A minimum of two years of experience in quality engineering.
  • Bachelor's degree in a relevant field such as science or engineering.
  • Proven understanding of quality concepts, practices, and methodologies.
  • Strong interpersonal and communication skills.
  • Ability to plan, coordinate, and execute testing and inspection procedures, conduct process capability studies, prepare statistical quality control data, and develop statistically designed experiments.
  • Familiarity with FDA 21 CFR Part 820 regulations.
  • Willingness to travel as required.
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