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Quality Engineer

Company: Jobot
Location: Redwood City
Posted on: August 5, 2022

Job Description:

Be a part of a growing medical equipment manufacturing company as a Quality Engineer!

This Jobot Job is hosted by Jake Benyshek

Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume.

Salary $100,000 - $130,000

A Bit About Us

We are a medical equipment manufacturing company. Our systems give physicians a big opportunity with an exceptionally small, high resolution, single-use advanced imaging system! It is ideal for a multitude of current procedures as well as optically guided injections, with numerous additional application possibilities in regenerative medicine.



Why join us?


If you want to be a part of the growth and success of an upcoming medical equipment manufacturing company that is already making waves in the industry with its innovative technology, this is the place to be!

Job Details

Experience

  • 2-5+ years of experience as a Quality Engineer in the medical device industry
  • BA/BS degree in science, engineering or other technical fields
  • Medical Device Quality System Knowledge Including 21 CFR Part 820 (QSR) & ISO 13485
  • Strong computer skills (MS Suite, Data Entry, etc.)
  • Experience participating in internal and external audits (e.g., FDA, Notified Body, Supplier)
  • Experience with Design Control, CAPA, complaint investigation, field action processes and risk management
    Responsibilities
    • Performing root-cause investigations to establish corrective action plans and implement corrective actions
    • Developing and performing test methods for product testing and investigations
    • Collaborate with R&D on DHF and technical files to ensure completion of design phases in a timely manner
    • Collaborate with Regulatory to ensure compliance to FDA Quality System Requirements (QSR) and ISO 13485 regulations and standards
    • Develop and assist in the development of process specifications, methods, validations, incoming inspections etc---
    • Develop quality related specifications and tests
    • Develop and conduct V&V protocols as needed
    • Collaborate with external test labs
    • Prepare product and operations for design transfer
    • Drive manufacturing and supplier controls
    • Support NCMRs, CAPAs, and Complaints completion
    • Support sterilization and packaging validation efforts
    • Manage supplier control system
    • Provide support for manufacturing by managing routine process logistics and reviewing results.
    • Provide support for environmental monitoring program and CER maintenance
    • Track and report quality metrics
    • Coordinate the documentation review, inspection workflow, training, problem solving and calibration for products and test equipment
    • Performs standard quality engineering reviews of design documentation for compliance with stated requirements, including supplier quality and company quality records
    • Works with manufacturing engineering to address supplier quality issues
      Interested in hearing more? Easy Apply now by clicking the "Apply" button.

Keywords: Jobot, Redwood City , Quality Engineer, Engineering , Redwood City, California

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