Job Purpose:
Enhance 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.
Key Responsibilities:
Supplier Assessment: Evaluate potential new suppliers for their technical, quality, and manufacturing capabilities. Provide technical support for the introduction of components from new suppliers.
Inspection Procedures: Create and maintain incoming inspection procedures and train inspectors on these procedures.
Inspection Tools: Develop and/or source inspection tools and equipment.
Component Specifications: Assist in generating component specifications.
Testing and Approval: Generate test protocols, monitor testing, issue qualification test reports, and approve components for use in products.
Design Engineering Support: Provide input to Design Engineering on new component technology and assist in component selection with quality and reliability analysis.
Defect Analysis: Analyze incoming material defects, determine dispositions, and drive corrective actions as necessary. Communicate issues to suppliers.
Design Review: Review new design specifications and provide input from a component quality and manufacturability perspective.
Field Failure Investigation: Investigate field failures related to supplier materials and develop corrective action plans as necessary.
Supervision: May supervise inspectors.
We 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 opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their 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 or uniformed service member status, 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
HR@insightglobal.com.
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Bachelor's degree in Biomedical Engineering or related engineering degree
Supplier Quality experience
Medical Device background
Proven track record of managing a Supplier Quality project
SAP knowledge
Windchill knowledge
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.