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

Pharmavise Corporation • Santa Clarita, CA

11d • Onsite

About The Position

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.

Requirements

• 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

Nice To Haves

• 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

Responsibilities

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1-10 employees