Senior Quality Engineer

2 weeks ago

Irvine, United States Motion Recruitment Full time

Title: Senior Engineer (Quality)

Location: Irvine, CA

Duration: Contract

About the Client:

Join a distinguished member of the Fortune 100 community, specializing in cutting-edge medical devices tailored for critical care, structural heart interventions, and surgical monitoring. With a rich heritage built upon values of integrity, collaboration, and relentless innovation, our partner stands at the forefront of revolutionizing healthcare. Key offerings include transcatheter heart valves, innovative transcatheter mitral solutions, advanced critical care monitoring systems, and state-of-the-art surgical valve technologies.

Overview:

This position will have a primary focus to lead in the development, improvement, maintenance, and management of suppliers. The Senior Engineer will apply knowledge of quality engineering principals and methods to ensure compliance with regulatory requirements and Companys systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.

Job Responsibilities:

  • Interpret engineering drawings, schematic diagrams, or formulas and confer with management or engineering staff to determine quality and reliability standards.
  • Participate in technical discussions with suppliers to identify and implement improvements in products and processes.
  • Participate in design and drawing reviews to ensure that components meet requirements for design and patient safety requirements.
  • Develop, validate, and improve component inspection strategies and methods to ensure parts meet drawing requirements.
  • Responsible for defining supplier qualification requirements for components and custom materials, including supplier validations, Companys receiving inspection test methods and fixture design.
  • Develop, update, and maintain technical content of part qualification plans and reports.
  • Investigate complex manufacturing product quality and compliance issues (e.g., NCR, CAPA, SCAR) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations, implement corrective actions, and document reports.
  • Perform other duties and responsibilities as assigned.

Skills:

  • Effective communication and conflict resolution skills, team player
  • Highly organized and detail oriented.
  • Effective problem-solving techniques (i.e. Root Cause Analysis, FMEA process, Gage R&R, Validation activities, etc.)
  • Conduct effective root cause investigations assessment of corrective action strategies and effectiveness as applied to NCRs and SCARs
  • Ability to make sketches, engineering drawings and common computations.
  • Ability to read and interpret technical drawing, schematics and computer-generated reports.
  • Previous experience with computer applications and software related to engineering field, such as Computer Aided Design (CAD).
  • Understanding of Risk Management principles
  • Previous experience with Keyence routine programming
  • Six Sigma Green or Black Belt/LEAN Manufacturing experience a plus
  • Ability to manage competing priorities in a fast-paced environment
  • Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations

Education/Experience:

  • Bachelor's degree (Engineering or Science) is required with 4 years of experience required or Masters Degree (Engineering or Science) and 3 years of related experience required

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