ICU Medical | Supplier Quality Engineer

hace 23 horas

nuevo león, México ICU Medical A tiempo completo

ICU Medical connects patients and caregivers through safe, life-saving, life-enhancing IV therapy systems, software, solutions, and consumables. Since IV therapy is our only business, meeting your IV needs with quality products and consistent supply is our only concern. We are 100% focused on bringing you intuitive, patient-centric IV products and services that provide meaningful clinical differentiation, consistent innovation, and superior value. We design our products to work within your existing workflows to minimize disruption and maximize the time you spend with patients. Together, we help forge the human and emotional connections that enhance clinical experience and are the essence of outstanding quality of care.

ICU Medical is looking for a responsible individual for improving supplier quality through supplier improvement plans and execution of them, coaching, and other supplier engineering activities.

Responsibilities:

  • Develop and improve supplier quality metrics and maintain and report supplier quality metrics.
  • Provide team leadership for small/large scale projects to implement supplier process and system improvement plans.
  • Assure timely resolution of supplier quality and technical issues.
  • Visit suppliers related to quality and technical issues audits.
  • Process ownership for supplier quality metrics.
  • Coaching of suppliers through validations.
  • Article quality assessments (AQA).
  • Supplier related complaint investigations.
  • Support quarterly site management review board and prepare data pertaining to material and supplier controls.
  • Verification of effective supplier corrective actions.
  • Up to 25% travel requirement.

Minimum Qualifications, Education & Experience:

  • Scientific University Degree (BS degree) required.
  • Degree in Engineering (or equivalent).

Technical Knowledge and Skills:

  • Minimum of 5 years engineering work experience in a Process, Quality, or Supplier Quality function.
  • Experience/familiarity with regulated product quality system requirements, i.e. ISO 13485, FDA Quality System Regulations, ISO 14971, and other applicable Standards.
  • Strong working knowledge of current international and company regulatory compliance requirements and operating procedures, including (but not limited to) FDA, ISO 13485, MDSAP, European Medical Device Directive and Medical Device Regulation, and applicable industry Standards.
  • Experience with supplier quality systems and processes including Supplier Corrective Actions (SCAR), Supplier Quality Agreements, Supplier Transitions, and Product Change Notifications.
  • Practical knowledge and experience in statistical analysis, problem-solving, Corrective and Preventive Action, Quality Plans, PFMEA, and manufacturing process Validation.
  • Must be able to read and understand component/product specifications.
  • Effective facilitation skills to lead discussions around root cause analysis, driving to consensus and resolution of identified non-conformances.
  • Proficient computer skills including electronic mail, project management, record keeping, and routine database activity, word processing, spreadsheet, graphics, etc.
  • Knowledge on PPAPs and statistical techniques.
  • Excellent verbal, written, and presentation communication skills. High attention to detail.

Abilities:

  • Able to act as a team leader on projects; supports peers and other team members, escalates concerns appropriately, able to act as temporary manager designee.
  • Self-starter with the ability to quickly learn about new processes, products, and projects.
  • Work effectively with cross-functional teams with the ability to leverage or engage others to accomplish tasks.
  • Ability to build strong working relationships within the organization and partnerships with suppliers.
  • Strong verbal and written communication skills, including the ability to write technical reports/presentations and to negotiate Supplier Quality Agreements.
  • Solid organizational and follow-up skills, as well as attention to detail.
  • Critical thinker with analytical problem-solving skills with the drive to resolve quality related issues in a timely and effective manner.

Strong presentation skills and able to effectively communicate with higher levels of management.

Seniority level
  • Mid-Senior level
Employment type
  • Full-time
Job function
  • Quality Assurance
Industries
  • Plastics Manufacturing and Medical Equipment Manufacturing
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