Senior Design Quality Engineer

Santa Clara, CA 95050

Posted: 03/25/2020 Employment Type: Contract Industry: Information Technology Job Number: 7716

Job Description


Our client develops, manufactures and supplies a wide array of innovative medical diagnostic products, services, tests, platforms and technologies.

 

Duties:

Applies intensive and diversified knowledge of design principles, practices, and implementation in complex systems and assignments. General responsibilities include, assisting with design concept generation, participating in design reviews, reviewing development protocols, and testing, to assess performance against design specification. Additionally, the candidate will review reliability testing, and assist in the risk assessment of system interactions. This role will make independent decisions.

The ideal candidate will consult and assist in the development of manufacturing processes and procedures, ensuring appropriate design transfer. Responsible for developing, implementing, and continuously improving defined processes which provide a methodical and systematic approach to ensuring that new and existing products and processes are effectively characterized and controlled prior to, and after launch. Facilitates and consults for risk management policies, procedures, and practices, which consolidate regulatory and quality system requirements with business goals resulting in an effective and efficient risk management system.

ESSENTIAL FUNCTIONS:
  • Practices and mentors in the use of company concepts, policies and procedures, familiar with and follows standard practices.
  • Applies functional expertise routinely on the job.
  • Receives general direction and exercises considerable discretion as to work details.
  • Contributes to the definition and timely achievement of overall project goals.
  • Participates in efforts to define new components, products or processes.
  • Identifies and implements improvements to work processes.
  • Designs, plans and executes project related tasks.
  • Consults and provides training for areas of statistical quality control such as SPC, Process capability, DOE, etc.
  • Assures experimental quality through sound, independent, experimental design.
  • Participates on cross functional technical teams.
  • Provides technical direction and feedback to others.
  • Participates in project planning, process updates and contributes to experimental design.
  • Monitors work to ensure quality, and continuously promote Quality First Time.

 

Job Requirements

Knowledge, Skills and Abilities:

  • Demonstrates success in technical proficiency, creativity, collaboration with others and independent thought.
  • Expert knowledge of applicable regulations and standards, including FDA QSR Part 820, ISO13485.
  • Expert knowledge of Quality engineering principles and concepts.
  • Experience in medical device, including software, reagents, and assay development, design control process.
  • Need software and medical device development understanding, partnered with Design Control regulations.

 

Formal Training/Education:

  • BS in a directly related discipline. Advanced studies or training.

 

Experience:

  • Typically requires a minimum of 8 years of related experience.
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