Senior QA Engineer

New Product Transfer Collaborate with R&D and Engineering to ensure product meets quality, manufacturability and reliability requirements from pilot build through production Provide quality oversight and guidance to internal teams and contract manufacturers throughout new product introduction and production transfer Participate in build readiness reviews, risk assessments, and issue resolution to ensure a seamless transition from pilot to full production Build strong collaborative relationships with suppliers to foster a culture of quality ownership and continuous improvement Support customer complaint investigations related to instruments, ensuring timely containment, root cause identification and CAPA implementation Support development and continuous enhancement of quality procedures, documentation and control processes Support internal and external audits, qualification and regulatory compliance efforts Bachelor's degree in Mechanical Engineering (or equivalent) Demonstrable experience in complex instrumentation or electro-mechanical system manufacturing within the Life Sciences or Medical Device industry Strong technical understanding of precision assemblies, motion systems (X-Y stage), instrument fixtures and testing tools Proven experience working with contract manufacturers and managing supplier quality and performance including participation in NPI cycles Experience in supplier development or Supplier Management/Vendor quality system enhancement Understanding of ISO 9001 and/or ISO 13485 quality management system requirements Knowledge of CAPA, nonconformance, deviation and SCAR management Strong problem-solving and analytical skills, with a track record of driving quality and process improvements Excellent communication and collaboration skills with cross-functional partners Professional quality certification such as CQE, CQA or Six Sigma Green/Black Belt Knowledge of software and firmware integration testing in complex instruments Proficiency with data analysis and quality tools (e.g. 8D, FMEA, SPC, Pareto)