Quality Engineer II — Medical Device (Onsite — Valencia, CA) Possible Contract Extension

Job Summary:

Responsibilities will include:

• Understanding failure modes and approving product analysis for return and non-return complaints related to mechanical medical devices performed by technicians
  

• Coordinating, training and supervising failure investigation activities for lab technicians
  

• Support integration of new products into CIS lab by creating/validating test methods and test instructions
  

• Creating and presenting slides for SER/CRB
  

• Collaborating with other Post Market (CCC/CMC) teams, R&D, Design Assurance, Manufacturing, Supplier to help determine root cause of complaints
  

• Monitoring product performance and escalating any non-conformance issues with returned device.
  

• Creating, releasing new WI/SOPs in document control system
  

• Initiating and owning non-conformance investigations
  

• Training technicians to find root cause of complaints through sound failure analysis techniques
  

Minimum Qualifications:

• Bachelor’s degree in Mechanical Engineering with 2+ years of relevant experience ***Bachelor's degree can be in electromechanical/electrical but the candidate needs to have hands-on experience in failure analysis.
  

• Demonstrated problem-solving & failure analysis capabilities of mechanical systems/components
  

• Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook
  

• Great written/verbal communication skills and ability to collaborate with other teams
  

• Ability to successfully multi-task and be adaptive
  

Preferred Qualifications:

• Masters degree in Mechanical Engineering with at least 1 year experience in similar role
  

• Ability to understand system level functionalities, to devise and validate test methods for failure analysis of systems/components
  

• Experience in Medical Device industry
  

• Familiarity with Post Market requirements and systems
  

• Familiarity complaint systems used for medical devices
  

• Experience with using SAP and PowerBI