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Quality Engineer

Adona Medical
Quality Assurance
Los Gatos, CA, USA
USD 100k-120k / year + Equity
Posted on Mar 25, 2026
     
  Position: Quality Engineer  
     Location:   Los Gatos, CA
  
  
  Job Id: 647  
  # of Openings: 1  
    
 Akura Medical, a Shifamed Portfolio Company, is focused on a differentiated approach delivering an effective solution to address the major challenges of venous thromboembolism (VTE). Akura recently announced the first-in-human use of its mechanical thrombectomy platform. Each year VTE affects as many as 900,000 Americans, resulting in about 100,000 premature deaths. To learn more about Akura Medical, please visit www.akuramed.com.
 
 ABOUT SHIFAMED
 Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.
 
 Description:
 
 Our Quality Engineer will proactively drive quality and compliance in manufacturing in a collaborative way. This position represents an exciting opportunity to join an innovative and high performing team and influence the design and development in early stages. As a key member of the team, you will actively lead nonconforming material reports (NCMR), equipment control, lot release testing, deviations process, incoming inspection review, and controlled environment room (CER) monitoring. This position also provides technical support to the Operations group. This position will also play an active role in the development and maintenance of the quality management system and ensure QMS compliance adherence. This is a full-time, on-site position and will require reporting to our offices located in Los Gatos, CA. 
 
 Responsibilities, Skills & Hands-On Experience: 
Lead Nonconforming Materials Reports (NCMR) investigation, identifying appropriate corrective actions and disposition of material.
Lead equipment control process including adding new equipment, reviewing equipment calibration / preventive maintenance, and investigation and disposition of equipment events.
Lead controlled environment room (CER) monitoring.
Develop quality inspection methods and processes in manufacturing and design.
Identify the need for Corrective Action Preventive Action (CAPA). Initiate, implement, and close CAPA's.
Collaborate closely with cross-functional teams, including Operations and R&D.
Excellent communication skills: ability to work both independently and in project team setting.
Ensure compliance with applicable regulations and standards, including FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
Education & Work Experience:
B.S. or higher in Biomedical, Electrical, Mechanical or Systems Engineering or equivalent relevant work experience.
3+ years of experience in a quality engineering role. Experience in the medical device industry with electromechanical products and/or interventional cardiology products is preferred.
C.Q.E. is a plus.
Our salary ranges are calculated by role, level, and location. Please note that your position within that range will be determined by your job-related knowledge, location, skills, experience, relevant education, and training/certifications. The base salary range for this full-time position is between $100,000 to $120,000 + equity + benefits.
  
 NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to hr@shifamed.com.

 
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