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 both new product development and production, executing supplier/company-initiated designs, design changes and resolving technical problems.

ESSENTIAL DUTIES AND RESPONSIBILITIES

include the following: Evaluate, define, and select appropriate supplier sources based on quality, service and cost for new product development projects and sustaining production. Execute purchase part approval process through creation of risk analysis (PFMEA), control plans, process capability (Cpk, Ppk) and measurement capability (Gage R&R) studies. Work with suppliers to ensure their production process will produce parts/product that meet or exceed Imperative Care specifications and capacity requirements. 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. Administer supplier change request assessments to analyze impact of requested change and properly test/validate to successfully accept and implement requested change. Actively promote and support the Quality Management System, Quality Objectives, and Quality Policy. Assure that you and functional subordinates (if applicable) are trained on all applicable procedures and processes according to Good Manufacturing Practices, applicable FDA, and Regulatory requirements. Actively promote and support the company's Management Review process. Inform responsible personnel of concerns involving product quality. Perform job functions in a safe and effective manner. Other duties as assigned.

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 molding is preferred. 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.

SUPERVISORY RESPONSIBILITIES

May oversee the work completed by colleagues involved in supplier qualification and sourcing validation activities. Benefits (employee contribution): Health insurance Health savings account Dental insurance Vision insurance Flexible spending accounts Life insurance Retirement plan All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Rate of pay within the stated range will depend on the qualification of the applicant. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the

California Fair Chance Act INDTS Pay:

$70.00 - $80.00 per hour

Benefits:

401(k) Dental insurance Health insurance Life insurance Vision insurance

Work Location:

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