Quality Engineer II - Medical Device; Onsite

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 Linked In:

Job Summary:

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.

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 helpdetermineroot 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

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

Other Details:

Schedule:

08:00:

AM - 04:30:

PM

Contract Length: 12 Months ( 5/25/2026 - 5/25/2027 ) and Possible Extension

Pharmavise 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.