SUMMARY: An individual in this role uses solid experience to collaborate with materials management team in sourcing identification, in change or improvement assessments of quality and service level including analysis of cost on sourced components and evaluation of supplier manufacturing processes. This position serves as key liaison between suppliers and production units, executing supplier/company-initiated changes and resolving technical problems.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:
• Perform risk analysis activities and develop risk-justified product testing or validation plans and protocols; review/present for approval supplier protocols for validation or performance testing; set up and run product testing and protocols in accordance with project plans.
• Support DCO, CAF, NCR, SCR reviews/approvals/initiation.
• Participate in the evaluation of supplier's technical competencies, capabilities, and capacity to provide input into sourcing reliable and cost-effective material supply decisions.
• Consult with R&D and manufacturing engineering to assess product requirements, reviewing studies product characteristics to select validation objectives and standards. Seek and provide supplier feedback on DFMs. Serve as the point of contact with suppliers for product specifications or engineering changes. Contribute to suppliers' onboarding materials.
• Collaborate with the Supplier Quality Engineering to ensure completion of audits for new and existing suppliers as required, support investigation of material quality issues as they arise and ensure that adequate corrective actions are identified, implemented by suppliers, driving supplier accountability actions. Establish and report metrics for Supplier Performance Monitoring and ensure adequate controls are in place to prevent supplier nonconformances.
• Work with suppliers to identify root cause of nonconformities of product or process standard and offers recommendations for resolving deviations.
• Support Continuous Improvement of Quality & Quality Systems, Service Capability and Total Cost of Ownership throughout the Supply Chain.
• Proactively conduct risk assessments on sourced materials and builds installed capacity and capability at suppliers' locations.
• Administer supplier change request assessments to analyse impact of requested change and properly test/validate to successfully accept and implement requested change.

EDUCATION/EXPERIENCE:
• Bachelor's degree in engineering, or related discipline and a minimum of 5+ years of related
experience; or equivalent combination of education and work experience.
• Knowledge of guide catheters, extrusion, injection moulding is preferred.
Docusign Envelope ID: B41D1DC1-C847-402F-A57D-3ED43C64B268
• Experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, the MDD, GMP, GDP procedures and requirements.
• Knowledge of operations techniques including Just-In-Time (JIT) manufacturing, benchmarking, and other quality and continuous improvement tools (Lean).
• Demonstrated technical skill in risk management and remediation processes.
• Ability to create detail project plans effectively.
• Familiar with Design Control procedures and requirements.
• Experience with test method validation, and product/process changes/validation.
• Excellent communications skills (both written and verbal) required.
• Ability to work independently or in team setting required.
• Working knowledge or experience in the purchasing of components and subsystems within a manufacturing and/or NPD environment.

Salary Range: $109,000 - $127,000 annually

Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position, candidate's work experience, education/training, key skills, and internal equity, as well as location, market and business considerations when extending an offer
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Employee Benefits include a stake in our collective success with stock options, bonus, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.