Quality Engineer II — Medical Device (Onsite — Valencia, CA) Possible Contract Extension Valencia, United States | Posted on 04/28/2026From 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. Visit us at www.Pharmavise.Com and follow us on LinkedIn: https://www.Linkedin.Com/company/pharmavisecorpJob Description Job Summary:Responsible for creating test methods, work instructions,trainingand mentoring technicians who work on investigation of return and not-return products. The QE will review result of investigations completed by others for accuracy,completenessand compliance to SOPs/WIs.The results of investigations can be used to escape product issues in collaboration with other Post Market functions, R&D, Design Assurance, Operations, Supplier Management, and Medical Safety.Responsibilities will include:Understanding failure modes and approving product analysis for return and non-return complaints related to mechanical medical devices performed by techniciansCoordinating, training and supervising failure investigation activities for lab techniciansSupport integration of new products into CIS lab by creating/validatingtest methods and test instructionsCreating and presenting slides for SER/CRBCollaborating with other Post Market (CCC/CMC) teams, R&D, Design Assurance, Manufacturing,



Supplier to helpdetermineroot cause of complaintsMonitoringproduct performance and escalating any non-conformance issues with returned device.Creating, releasing new WI/SOPs in document control systemInitiating and owning non-conformance investigationsTraining technicians to find root cause of complaints through sound failure analysis techniquesMinimum 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/componentsProficient with Microsoft Office tools including Word, Excel, PowerPoint, and OutlookGreat written/verbal communication skills and ability to collaborate with other teamsAbility to successfully multi-task and be adaptivePreferred Qualifications:Masters degree in Mechanical Engineering with at least 1 year experience in similar roleAbility to understand system level functionalities, to devise and validate test methods for failure analysis of systems/componentsExperience in Medical Device industryFamiliarity with Post Market requirements and systemsFamiliarity complaint systems used for medical devicesExperience with using SAP and PowerBIOther Details:Schedule: 08:00:AM - 04:30:PMContract Length: 12 Months ( 5/25/2026 - 5/25/2027 ) and Possible ExtensionPharmavise Corporation is an Equal Opportunity Employer and does not discriminate on the basis of race or ethnicity, religion, sex, national origin, age, veteran disability or genetic information or any other reason prohibited by law in employment.#J-18808-Ljbffr

📌 Quality Engineer Ii — Medical Device (Onsite — Valencia, Ca) Possible Contract Extension
🏢 Pharmavise
📍 Valencia