The Supplier Quality Engineer (SQE) is the principle interface between Cogmedix and the supplier quality organizations. The supplier quality engineer will work with quality organization of the Cogmedix supply chain in the investigation and resolution of any supplier related issues. The SQE will also work with the suppliers to proactively prevent issues of occurring as well as recurring issues.
- Provide technical support to internal customers and suppliers for activities related to supplier quality system assessment, performance evaluation, and supplier development.
- Responsible for supporting Supplier Development initiatives for current and new potential suppliers and for implementing quality related-programs and projects and will serve as liaison between suppliers and Cogmedix operations to drive supplier improvement.
- Identify supplier non-conformance trends. Track supplier quality performance measurements for strategic suppliers.
- Lead supplier visits, audits and source inspections. Support and enhance the supplier selection and certification
- Lead and participate in supplier development projects and continuous improvement activities focusing on supplier quality.
- Collaborate with suppliers on inspection requirements and methodologies and reporting of inspection results to Cogmedix.
- Drive suppliers to identify appropriate quality assurance systems that will ensure receipt of defect free components/materials.
- Champion the MRB process for supplier caused defects. Communicate identified issues, and drive corrective action and preventive actions by the suppliers.
- Support the new Scaled Product Launch™ development process as necessary. Support /coordinate quality requirements between Cogmedix and supplier as necessary.
- Maintain current knowledge of relevant technologies, materials, equipment, and processes. Develop and maintain an understanding of industry and market trends and competition.
- Develop, deliver and ensure in-house training programs for company personnel in order to ensure regulatory compliance.
- Drive improvements in suppliers’ quality performance.
- Develop quality metrics to evaluate supplier performance.
- Support supplier quality management programs such as supplier selection and certification.
- Manage, track and trend all supplier corrective actions requests.
- Drive resolution of supplier corrective action requests.
- Other duties as assigned.
- Positive attitude, well organized, self-motivator, and tenacious follow up required.
- Superior customer service attitude.
- Excellent teamwork in various disciplines and on multi-functional teams, communication, and interpersonal skills.
- Bachelor’s degree, preferably in a science or engineering discipline. Significant and applicable professional experience may be considered in lieu of certain educational requirements.
- Strong electro-mechanical and opto-mechanical orientation preferred.
- Experience in ISO-13485 certified environment and cGMP organizations preferred.
- Proven analytical and problem solving skills.
- Knowledge of IPC 610 and 620 standards beneficial.
- Advanced Level Skills in MS Word and Excel such as keyboard short cuts, creating macros and forms, table techniques, working with images and text, pivot tables.
- Advanced Level Skills in MS Visio such as creating Visio diagrams, creating custom styles and templates, cross functional flow charts, linking drawings to other MS applications, working with data, custom reports, and exporting is valuable.
- 5+ years in medical subassembly and finished device manufacturing supplier quality or supply chain management preferred and/or engineering that included driving supplier performance improvements and/or meeting and organization’s needs.
- Demonstrated understanding of Statistical Process Control (SPC) and experience implementing SPC or similar controls.
- Experience with molded plastics, sheet metal, cables and wire harness, PCB’s, electronics, and machined parts desirable.
- Six Sigma certified desirable.
- Physical requirements:
- Standing for prolonged periods of time.
- Lifting up to 30 pounds.