Quality Engineer Job

Quality Engineer needed to perform the below:

Support and implement quality systems and compliance standards across regulated manufacturing environments, focusing on FDA remediation and documentation compliance activities
Review, assess and update Device Master Records (DMRs), manufacturing instructions, validation protocols, reports and standard operating procedures to ensure alignment with internal procedures and regulatory requirements.
Execute validation and qualification activities, including IQ, OQ and PQ.
Collaborate with cross-functional teams, including Manufacturing, Engineering, Operations and Quality to support investigations, root cause analysis, CAPA and continuous improvement initiatives.
Serve as Subject Matter Expert (SME) on lab capabilities, including GMP and non-GMP equipment, software, and data acquisition systems for Design Verification testing.
Responsible for equipment and software qualification, SOPs and work instructions, resolving issues, training operators, and representing combination product development on cross-functionally validated systems.
Lead lab verification activities, including design verification protocol development, test method development, test execution, data analysis and documentation, and report writing. Support investigations and issue resolutions. Present results to cross-functional teams.
Utilize volumetric accuracy equipment and force testing machine. Familiarity with Zwick, viscometers, climate chambers, etc.
Support data analysis using statistics; experience with Minitab is a plus.
Develop, validate, and transfer test methods.
Utilize machine shop equipment, SolidWorks, and 3D printers to design and verify test method fixtures.
Experience with SolidWorks, Electronic Lab Notebook (ELN) software, and electronic DHF tools such as Polarian is preferred.

Bachelor's degree in Mechanical Engineering

Health/Dental Benefits, Relocation Assistance, Offers Sponsorship for U.S. Visa