Quality Engineer

2 weeks ago

Irvine, United States TalentBurst Full time

Position: Senior Quality Engineer, Req#: 6228-1

Location: Irvine, CA (100% onsite)

Duration: 18 Months Contract

Job Description:

We have an opportunity for a Senior Engineer on the Transcatheter Heart Valve (THV) New Product Development Supplier Quality team. 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 principles and methods to ensure compliance with regulatory requirements and the clients systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.

Education and 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
  • Inspection development, Minitab/data analysis, Project management/organization/planning experience required
  • Specific technology/software: MS Office, Keyence, Smartscope, Solidworks, Minitab, PowerBI
  • Risk management, Solidworks/Creo, Six Sigma: Nice to have

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 drawings, schematics, and computer-generated reports.
  • Previous experience with computer applications and software related to the 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

Roles and Responsibilities:

  • Meeting with cross-functional team members, developing inspection methods & fixturing, reviewing/analyzing data, tracking & reporting on status, validation protocol/execution/reports, supporting receiving inspection issues
  • 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, Edwards 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 before final product release based on engineering principles; analyze results, make recommendations, implement corrective actions, and document reports.
  • Perform other duties and responsibilities as assigned.

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