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Supplier quality vendor Engineer (for medical industry) 441

  • Della Infotech Inc.
  • Sunnyvale, CA, USA
  • Mar 26, 2020

Job Description

Job Description


Primary Function of Position: Supplier Engineering

Responsible for ensuring suppliers meet ISI requirements for cost, quality, delivery and service. Drive suppliers to continuously improve business and manufacturing processes. Evaluate and select suppliers. Guide Engineering in choosing suppliers for new products and provide DFM input to new designs. Monitor supplier performance.

Roles and Responsibilities:

A Supplier Engineer has responsibility and authority to:
• Select and evaluate suppliers by leading efforts to find new suppliers in an existing or new commodity.
• Work with suppliers and ISI engineering for the new product introduction to
o Complete part production qualification process ( PPQP), which includes but not limited to delivering on the following deliverables: spFMEA, Special Process Validations, Process capability, MSA, capacity analysis ,and FAIR .
o Develop supplier ramp readiness based on forecast, supplier capacity, quality performance, and process capability.
o Perform DFM by engaging suppliers early in development cycle to feedback manufacturability improvements in the designs prior to production
• Lead and resolve the supply continuity/ quality issues at suppliers through in depth root cause and corrective actions utilizing SCARs, SCRs (Supplier Change requests) processes.
• Monitor supplier performance and initiate improvement activities.
• Drive suppliers to continually improve their business and manufacturing process performance to meet company’s requirements for supplier excellence including ship to stock programs using a collection of best practices in project management, Six Sigma, Lean, SPC and negotiation by leading these efforts without managerial guidance at several suppliers simultaneously.
• Develop and use metrics for supplier part cost, delivery, quality, capacity and capability by creating metrics to measure real improvement and judge required intervention or change at the supplier or in a commodity.
• Driving change to ISI specifications as necessary by understanding and changing specifications and drawings including driving the ECO process to implementation.
• Conduct on-site supplier assessments as well as QMS audits and address the non-conformities.
• Prepare and deliver supplier communications as required by independently working with suppliers on scorecard creation of QBRs, Supplier Summits, etc.
• Identify and investigate opportunities for cost reduction and/or quality improvement by judging opportunities and creating strategies to seize those opportunities, completes research and provides data-driven plans to management.

Skill/Job Requirements:

In order to adequately perform the responsibilities of this position the individual must possess:
• BS degree in Engineering or equivalent, Masters degree preferred
• Excellent knowledge of 21 CFR part 820 and ISO 13485 (experience in auditing suppliers to these standards): Certified Lead auditor preferred, but not required
• Practical knowledge of pfmeas 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
• A 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 Information 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 – domestic and international

• Supplier management experience (Temp)
o Min 3 years of experience in managing electronic, metal or medical suppliers
o Experienced and Practical knowledge in part production qualification process for new and alternative parts, including but not limited to supplier process validation, change control process, capability/FMEA/FAIR assessment
• Experienced in supplier project management:
o Able to define supplier project scope, schedule, and proactively track project performance, specifically to analyze the successful completion of short- and long-term goals.
o Able to communicate and Influence supplier/multifunctional team to collaboratively complete the project, and deliver parts on time that meet ISI requirements.
• Prefer to have experience in Supplier Audit

Company Description

Della Infotech Inc is in staffing business for five years. Over the years, we have placed hundreds of candidates to various temp and permanent positions with our 50+ happy clients all over US and Canada including Fortune 500 corporations.