28 oct
|
Pharmavise
|
Valencia
28 oct
Pharmavise
Valencia
Quality Engineer II — Medical Device (Onsite — Valencia, CA) Possible Contract Extension
From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues.
We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology.
Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety.
Responsible for creating test methods, work instructions,trainingand mentoring technicians who work on investigation of return and not-return products.
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/validatingtest methods and test instructions
Monitoringproduct performance and escalating any non-conformance issues with returned device.
Creating, releasing new WI/SOPs in document control system
Training technicians to find root cause of complaints through sound failure analysis techniques
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
Ability to understand system level functionalities, to devise and validate test methods for failure analysis of systems/components
Experience in Medical Device industry
Familiarity complaint systems used for medical devices
Experience with using SAP and PowerBI
Contract Length: 12 Months ( 5/25/2026 - 5/25/2027 ) and Possible Extension
📌 Quality Engineer Ii - Medical Device (Onsite Valencia)
🏢 Pharmavise
📍 Valencia