19 oct
|
Pharmavise
|
Valencia
19 oct
Pharmavise
Valencia
Quality Engineer II — Medical Device (Onsite — Valencia, CA) Possible Contract Extension
Valencia, United States | Posted on 04/28/2026
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. Visit us at and follow us on LinkedIn:
Job 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 escalate 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 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
Creating and presenting slides for SER/CRB
Collaborating with other Post Market (CCC/CMC) teams, R&D;, Design Assurance, Manufacturing, Supplier to helpdetermineroot cause of complaints
Monitoringproduct 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 Qualificatio
📌 Quality Engineer II (Valencia)
🏢 Pharmavise
📍 Valencia