OrthAlign Inc. logo

OrthAlign Inc.

Design Quality Engineer

300 - RA & QA · Aliso Viejo, California
Department 300 - RA & QA
Employment Type Full-Time
Minimum Experience Mid-level

OrthAlign, Inc., a Smart Technology, growing medical device company, has an immediate opening for a Design Quality Engineer responsible for performing design quality activities and supporting on-market products, new product development, and continual process improvement initiatives.

Using your Bachelors degree and your 3+ years of experience in medical device/operation, you'll interpret and apply your knowledge of ISO 13485, ISO 14971, and 21 CFR Part 820 to design controls, risk management, and statistical controls.

Here's what you'll do:

  • Provide quality assurance input and review of design and development planning, inputs/outputs of development, design reviews, design validation and verification, human factors analysis, design history file and device master record development and maintenance.
  • Drive risk management file establishment and maintenance throughout the product life-cycle.  Assist in establishing hazards list, assessing severity of harm and ensuring consistency between risk management files on systems.
  • Support CAPA investigation teams relating to product functionality and design improvement.  Support audits of the quality management system, specifically relating to Design Control, Risk Management, CAPA, Complaints, and related processes.
  • Assist the development team in creating, optimizing and validating mechanical and analytical test methods.
    Supporting regulatory submissions by reviewing content for accuracy and comprehensiveness.
  • Identify, propose and drive opportunities for improvement, including review and revision of procedures and associated documents.

We offer:

  • Innovative products
  • Awesome benefits
  • Great coworkers
  • An evolving, engaging culture and work space

It is an exciting time at OrthAlign - make your next career move with us!

This role does not offer sponsorship.

Thank You

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  • Location
    Aliso Viejo, California
  • Department
    300 - RA & QA
  • Employment Type
    Full-Time
  • Minimum Experience
    Mid-level