Katalyst CRO
Overview
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Supplier Quality Engineer
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Katalyst CRO Get notified about new Supplier Quality Engineer jobs in
Sunnyvale, CA . Responsibilities
Select and evaluate suppliers by leading efforts to find new suppliers in an existing or new commodity. Conduct on-site supplier assessments as well as QMS audits and address non-conformities. Work with suppliers and ISI engineering for the new product introduction to Complete part production qualification process (PPQP), including deliverables such as spFMEA, Special Process Validations, Process capability, MSA, capacity analysis, and FAIR. Develop supplier ramp readiness based on forecast, supplier capacity, quality performance, and process capability. Perform DFM by engaging suppliers early in development cycle to feedback manufacturability improvements in the designs prior to production. Lead and resolve supply continuity/quality issues at suppliers through root cause analysis and corrective actions utilizing SCARs and SCRs (Supplier Change Requests). Monitor supplier performance and initiate improvement activities. Drive suppliers to continually improve their business and manufacturing process performance to meet ISI/Intuitive Surgical requirements for supplier excellence, including ship-to-stock programs, using project management, Six Sigma, Lean, SPC, and negotiation, across multiple suppliers. Develop and use metrics for supplier part cost, delivery, quality, capacity, and capability to measure real improvement and determine required intervention. Drive changes to ISI specifications as necessary by understanding and changing specifications and drawings, including driving ECO implementation. Prepare and deliver supplier communications, including scorecard creation and QBRs/Supplier Summits. Identify and investigate opportunities for cost reduction and/or quality improvement with data-driven plans to management. Requirements
BS degree in Engineering or equivalent; master's degree preferred. Excellent knowledge of 21 CFR Part 820 and ISO 13485 (experience auditing suppliers to these standards); Certified Lead Auditor preferred but not required. Practical knowledge of PFMEA and process validations. Ability to read and interpret detailed mechanical drawings and communicate technical information. Excellent problem solving and project management skills. Excellent written and verbal communication skills including presentations to executive level management. Proven history of implementing Lean/6 Sigma/SPC programs at suppliers. Practical knowledge of part production qualification process. Significant computer experience using Windows, Word, Excel, Access and ERP systems, preferably SAP. CAD experience with 3D modeling tools is a plus. Experience in a high-volume medical device company is a plus. Ability to travel to suppliers on an as-needed basis domestically and internationally. Seniority level
Associate Employment type
Contract Job function
Quality Assurance Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x
#J-18808-Ljbffr
Join to apply for the
Supplier Quality Engineer
role at
Katalyst CRO Get notified about new Supplier Quality Engineer jobs in
Sunnyvale, CA . Responsibilities
Select and evaluate suppliers by leading efforts to find new suppliers in an existing or new commodity. Conduct on-site supplier assessments as well as QMS audits and address non-conformities. Work with suppliers and ISI engineering for the new product introduction to Complete part production qualification process (PPQP), including deliverables such as spFMEA, Special Process Validations, Process capability, MSA, capacity analysis, and FAIR. Develop supplier ramp readiness based on forecast, supplier capacity, quality performance, and process capability. Perform DFM by engaging suppliers early in development cycle to feedback manufacturability improvements in the designs prior to production. Lead and resolve supply continuity/quality issues at suppliers through root cause analysis and corrective actions utilizing SCARs and SCRs (Supplier Change Requests). Monitor supplier performance and initiate improvement activities. Drive suppliers to continually improve their business and manufacturing process performance to meet ISI/Intuitive Surgical requirements for supplier excellence, including ship-to-stock programs, using project management, Six Sigma, Lean, SPC, and negotiation, across multiple suppliers. Develop and use metrics for supplier part cost, delivery, quality, capacity, and capability to measure real improvement and determine required intervention. Drive changes to ISI specifications as necessary by understanding and changing specifications and drawings, including driving ECO implementation. Prepare and deliver supplier communications, including scorecard creation and QBRs/Supplier Summits. Identify and investigate opportunities for cost reduction and/or quality improvement with data-driven plans to management. Requirements
BS degree in Engineering or equivalent; master's degree preferred. Excellent knowledge of 21 CFR Part 820 and ISO 13485 (experience auditing suppliers to these standards); Certified Lead Auditor preferred but not required. Practical knowledge of PFMEA and process validations. Ability to read and interpret detailed mechanical drawings and communicate technical information. Excellent problem solving and project management skills. Excellent written and verbal communication skills including presentations to executive level management. Proven history of implementing Lean/6 Sigma/SPC programs at suppliers. Practical knowledge of part production qualification process. Significant computer experience using Windows, Word, Excel, Access and ERP systems, preferably SAP. CAD experience with 3D modeling tools is a plus. Experience in a high-volume medical device company is a plus. Ability to travel to suppliers on an as-needed basis domestically and internationally. Seniority level
Associate Employment type
Contract Job function
Quality Assurance Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x
#J-18808-Ljbffr