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Quality Engineer

CoLabs Medical
San Jose, CA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Quality Engineer

CoLabs Medical is seeking a very smart, technical, methodical, and organized person with high energy and great attention to detail to join our quality/engineering team.  CoLabs is a well-funded SF Bay Area startup medical device company developing the Ventor, an emergency airway and ventilation system, which will consistently deliver the new standard of care.  Born from experience and designed with passion, the Ventor changes how airway management and ventilation are approached during cardiac arrest.  A successful candidate possesses the ability to self-start, a strong collaborative mindset, and the ability to thrive in a dynamic environment.

About the Role

Quality Engineers focus on developing failsafe-designed and well tested products.  This position is a highly technical one.  We are looking for someone who has an engineering background so that they can rigorously challenge the design of the Ventor to ensure it is robust and performs to specifications throughout the product lifecycle and also has the experience to manage our QMS.  You will be the first Quality Engineer at CoLabs, and therefore will be responsible for making major decisions that impact the company’s success.

Responsibilities

  • Develop product and process verification and validation testing plans, protocols, and reports
  • Design or specify inspection and testing processes and equipment
  • Work hands on with technicians to conduct testing
  • Be the champion for design reviews, and challenge product designs for robustness
  • Assist Manufacturing Engineering in failsafing the design and manufacturing processes
  • Apply statistical methods to the design and testing of products
  • Own and lead the risk management process and apply ISO14971 risk management principles to product development, manufacturing, and post-market activities
  • Guide, assess, and validate design improvements and engineering change orders
  • Conduct all product validations, including transportation testing and packaging validation
  • Review and audit design and manufacturing documentation
  • Work with Manufacturing Engineering to implement a supplier quality program as well as select and audit key suppliers
  • Work with Regulatory Affairs to feed product testing data into regulatory submissions
  • Manage and maintain a “best in class” Quality Management System in accordance with FDA Regulation 21 CFR 820 and ISO 13485
  • Serve as the Management Representative 
  • Host external and internal audits 
  • Implement scorecards and analytical methods to track and develop quality metrics 
  • Develop and review standards, policies, and procedures in support of DHF and DMR activities

Required Characteristics

  • Have exceptional technical (engineering and statistics) skills  
  • Be incredibly well organized and detail oriented
  • Have a bias for action and be willing to take a hands on approach
  • Have a team-first mentality
  • Be naturally curious and love to learn

Base Qualifications

  • BS in Engineering or equivalent 
  • 10+ years taking medical products through the risk management, design verification, design validation, and process validation phases
  • Experience must include both electromechanical durable medical equipment (with software) and high volume medical disposables, spanning at least 3 different companies/product lines
  • Needs to be extremely well versed in the theory, principles, and application of statistical methods and statistical process control
  • Experience with supplier management and supplier certification 
  • Experience with transportation testing and packaging validation
  • Must be hands on, and willing to spend time in the lab conducting testing
  • Knowledge of medical device technical documentation such as Design Plans, IFUs, User Requirements, Intended Use statements, etc.
  • Deep knowledge of inspection and control methods, techniques, and documentation
  • Expert in authoring quality documents (SOPs, WIs, Templates, etc.)

Preferred Experience

  • Experience managing Quality Management Systems 
  • Six sigma, lean manufacturing or other certification/experience  
  • ASQ CQE Certification 
  • Certified auditor

Note:  This position is required to spend a majority of each week on site in our Morgan Hill offices and may require up to 10% US travel.

CoLabs Medical

Why Work Here?
Born from experience and designed with passion, the Ventor changes how airway management & ventilation are approached during cardiac arrest.

Address

San Jose, CA
USA

Industry

Manufacturing

Website

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