Sign up  

Follow Us!

Quality System Engineer - Medical Device

Company Name: KARL STORZ
Location: EL SEGUNDO, CA
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Job Description


  • Manage projects for QS CAPA in North America.
  • Provide direction and support for multiple company locations adopting changes to the global Quality System framework.
  • Implement/maintain Quality System that is compliant with FDA and ISO 13485
  • Ensure alignment with corporate standards and cGMP guidelines as well as assisting in increasing reported quality metrics.
  • Provide coaching and mentoring to global process owners through effective support of QMS.
  • Collaborate with management from all sites to facilitate and ensure company practices are consistent and compliant. 
  • Facilitate meetings to engage global leadership on Quality System framework and initiatives.
  • Create, maintain and utilize a “Standard Work” approach to perform tasks and produce deliverables needed to support teams, develop solutions and manage projects.
  • Manage cross-functional teams to meet project plans including timelines and budgets.
  • Support Quality metrics: Collect, maintain, trend, and analyze data.
  • Leverages various software programs such as Word, Excel, SAP and other necessary programs or project tools to manage and analyze data and complete work. 
  • Set short term and long term goals for continuous improvements (e.g., using Value Stream Mapping) to reduce costs, eliminate waste and improve processes to achieve product quality, customer satisfaction, and other key performance indicators.

Job Requirements


  • A Bachelor’s degree, preferably in areas engineering or science. Experience as a Quality Engineer –
    required; in a medical device manufacturing environment -
  • Certificates in quality would be a plus (e.g. CQM, CQE, CQA)
  • Project Management desired


  • Expertise in Quality Systems for medical devices.
    a.  Quality Management System and Medical Device experience, knowledge of 21 CFR Part 820, ISO 13485
    b.  Sterilization experience is a plus.
    c.  Hands-on experience leading CAPA projects in regulated environments.
    d.  Conduct CAPA analysis to determine root cause and complete problem resolution.
    e.  Ensure process changes are implemented per change control procedures.
  • Demonstrated knowledge and understanding of regulations and guidelines governing the areas of medical device development and manufacturing.
  • Ability to organize complex information into meaningful structures appropriate for diverse audiences.
  • Possess a broad knowledge of functional areas impacted by Quality Systems.
  • Demonstrated track record of systematically improving global Quality Systems.
  • Experience in leading cross functional teams.
  • Project management skills, including: set priorities, analyze risks, and make appropriate judgments and decisions.
    a.  Strong command of problem solving techniques and ability to coach others in their application.
  • Excellent written and verbal communication skills.