Job Description
nJob Purpose:
nEnhance the quality of components sourced from external suppliers by driving improvements and corrective actions. Provide technical support in supplier selection and develop acceptance criteria for materials. Monitor supplier performance to address corrective actions, manufacturing yield issues, and field failures. Most of the SQE IIs time will be dedicated to desk work, including data analysis, documentation, and communication with suppliers and internal teams. Additionally, the SQE II will visit supplier facilities to conduct audits, evaluate processes, and ensure adherence to quality standards. The candidate will also oversee testing and inspection in labs and on manufacturing floors to support smooth process improvements.
nKey Responsibilities:
nSupplier Assessment: Evaluate potential new suppliers for their technical, quality, and manufacturing capabilities. Provide technical support for the introduction of components from new suppliers.
nInspection Procedures: Create and maintain incoming inspection procedures and train inspectors on these procedures.
nInspection Tools: Develop and/or source inspection tools and equipment.
nComponent Specifications: Assist in generating component specifications.
nTesting and Approval: Generate test protocols, monitor testing, issue qualification test reports, and approve components for use in products.
nDesign Engineering Support: Provide input to Design Engineering on new component technology and assist in component selection with quality and reliability analysis.
nDefect Analysis: Analyze incoming material defects, determine dispositions, and drive corrective actions as necessary. Communicate issues to suppliers.
nDesign Review: Review new design specifications and provide input from a component quality and manufacturability perspective.
nField Failure Investigation: Investigate field failures related to supplier materials and develop corrective action plans as necessary.
nSupervision: May supervise inspectors.
nWe are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form ( . The EEOC "Know Your Rights" Poster is available here ( .
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nSkills and Requirements
nBachelor's degree in Biomedical Engineering or related engineering degree
nSupplier Quality experience
nMedical Device background
nProven track record of managing a Supplier Quality project
nSAP knowledge
nWindchill knowledge 2-3 years of Supplier Quality experience in the med device field null
nWe are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to