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Quality Engineer II - Medical Device


This exciting position is for a Medical Device Quality Engineer who wants to broaden their skills and take on diverse responsibilities as part of a fast-growing advanced medical technology company that will impact millions of lives. In this capacity, the role of the Quality Engineer will provide manufacturing support in a quality role (owning quality documents, authoring quality inspection procedures during R/I, manufacturing, and product release). The Quality Engineer will support R&D product specifications, test procedures, etc. The job requires excellent communication skills, and comfort working in a fast-paced, rapidly growing startup environment. If you are looking for a challenge and want to make a meaningful contribution, then this is the perfect role for you.


  • Assist and/or investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.  
  • Assist and/or develop complex experiments and tests (including writing and executing protocols – IQ, OQ, PQ) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports. 
  • Understanding and use of statistical analysis to provide product confidence and reliability for receiving inspection, testing in process and final critique.
  • Optimize complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement.  Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, collect relevant data, and reduce risk.
  • Develop, update, and maintain technical content of risk management files 
  • Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes.
  • Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work. 
  • Solid problem-solving, organizational, analytical and critical thinking skills.
  • Knowledge of and adherence to Quality Systems.
  • Understand and manage supplier quality (e.g. supplier notifications if Non-Conformances are dispositioned as RTV for rework, design changes that effect supplier work instructions, etc.).
  • Must be able to work in a team environment, including the ability to manage vendors and project stakeholders.
  • Ability to manage competing priorities in a fast-paced environment.
  • Ability to build productive internal/external working relationships
  • Develops solutions to a variety of problems of scope and complexity.
  • Contributes to process improvements. 


  • Bachelor's Degree or equivalent in Engineering required – Mechanical, Industrial, Manufacturing, Materials.
  • Minimum of 5-7 years experience OR Master's Degree + internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education required.
  • CQE (Certified Quality Engineer) preferred but not required.
  • Good computer skills in usage of MS Office Suite; CAD & Solidworks experience preferred.
  • Good documentation, communication and interpersonal relationship skills including negotiating and supplier relationship skills.
  • Basic understanding of statistical techniques.
  • Previous experience working with lab/industrial equipment required.
  • Working knowledge of LEAN and SIX Sigma methodologies.
  • Ability to learn & teach new technology and methods.

Benefits & Perks

  • Annual salary of 65k - 75k + equity, commensurate on experience
  • Competitive salary and stock options
  • Medical, dental, vision and disability
  • Flexible work schedules


Located in the hotbed of innovation near Irvine's University Research Park, we are a fast-paced Silicon Valley backed dental device company. If you are looking for a work environment with a positive culture that will empower and challenge you, we encourage you to submit your resume for review. 

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