Quality Engineer

Location: San Francisco Consulting
Department: Azzur San Francisco LLC

Job Description

Essential Duties and Responsibilities

Azzur personnel are expected to live up to our core values at all times and exhibit a high level of integrity and personal responsibility, especially when interacting with our valued clients. The following is a short list of the typical responsibilities and deliverables of any given project. The level of knowledge expected will be commensurate with level of incoming experience.

  • Provide quality engineering support to manufacturing lines, including floor support, non-conforming product investigations, change order control requests reviews, and new equipment qualifications, and be a factory-focus team member. 
  • Perform return product investigations for product complaints. 
  • Monitor manufacturing quality rates and develop reports to communicate performance for manufacturing lines. 
  • Perform key deliverables in support of development and continuous engineering R&D projects, which may include: mold tool qualifications, component qualifications, design and product risk assessments, shelf life validations, and sterilization validations
  • Work with manufacturing and R&D engineers to prepare work instructions, material specifications, and inspection documentation for new products. Set inspection requirements, set inspection methods and inspection sampling plans. 
  • Support and test component changes to current products. 
  • Support internal audits and supplier audits. 

Requirements

  • Bachelors  degree in Engineering
  • At least 5 years’ experience of quality experience in a regulated, manufacturing environment within the medical device industry.
  • ASQ-CQA certification
  • Must have previous experience using Master Control  
  • Strong communication skills 


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