Job Information
US Tech Solutions Quality Engineer II in Valencia, California
$50-$54 per hour
Valencia, CA
Contract
Duration: 12 Months Contract
About This Role:
Responsible for creating test methods, work instructions, training and mentoring technicians who work on investigation of return and not-return products. The QE will review result of investigations completed by others for accuracy, completeness and compliance to SOPs/WIs. The results of investigations can be used to escalate product issues in collaboration with other Post Market functions, R&D, Design Assurance, Operations, Supplier Management, and Medical Safety.
Your 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 devices
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
What We're Looking for in You:
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
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.