This job was posted by https://illinoisjoblink.illinois.gov : For more information, please see: https://illinoisjoblink.illinois.gov/jobs/12513623 Job Description

Position Summary

The Quality Systems Engineer II, Material Compliance, will support the ICU Quality Engineering Department and report to a Sr. Quality Engineering Manager. The Quality Systems Engineer II, Material Compliance is responsible for supporting functional activities associated with material compliance for medical devices managed under ICU Medical\'s Quality Management System. This position will coordinate, manage, initiate, and maintain material compliance and restricted substance assessments for ICU Medical products. This position will contribute to and, in some cases, lead quality improvements to the material compliance system and/or other systems. Completes intermediate to advanced projects with minimal guidance from more experienced engineers and managers. Work is generally independent in nature.

Essential Duties & Responsibilities

• Immediate Expectations:

  • Evaluate material and restricted substance compliance against industry regulations such as REACH, RoHS, California Prop 65, Conflict Minerals, EU Waste Framework Directive, etc.
  • Maintain the material compliance database and certification for impacted parts and finished goods in the PLM systems.
  • Collaborate with teams and other engineers on restricted substance assessments and other deliverables as part of sustaining engineering and new product development.
  • Respond to customer inquiries needing input for restricted substances.
  • Participate in process improvement efforts for material compliance.
  • Review and revise departmental standard operating procedures, as required.
  • Provide troubleshooting and training support for employees on PLM systems.
  • Conducts independent analysis and develops solutions to problems.
  • Work on special projects as they arise.
  • Delivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration.

{=html} <!-- --> - Long Term Expectations:

- Lead material compliance improvements projects and maintain the system to state of the art standards. - Identify inefficiencies in process workflows for material compliance in PLM IT systems and devise appropriate solutions and improvement initiatives. - Perform or support periodic material compliance audits (planned or unplanned). - Participate in process improvement efforts in Design Control & Risk Management programs. - Support initiatives for continuous quality improvements.

Knowledge & Skills:

• Knowledge of REACH, RoHS & California Prop 65 regulations.
• Knowledge of the Medical Device Industry, FDA QSR regulations, and ISO 13485 standard.
• Technical writing competency.
• Has a basic understanding of best practices. Has a basic to intermediate understanding of engineering discipline.
• Strong verbal and written communication skills.
• Excellent organizational skills.
• Ability to receive general project direction and solicit input from more experienced engineers.
• Requires the ability to independently make decisions that impact the attainment of project objectives.

Minimum Qualifications, Education & Experience:

• Must be at least 18 years of age.
• Bachelor\'s degree from an accredited college or university materials science, engineering, or related disciplines required.
• Minimum two years\' experience in an engineering, quality, or compliance position.
• Working experience in material compliance and ass ciated regulations, in the medical device industry. For example: REACH, RoHS, California Prop 65, Conflict Minerals, PG&C, EU Waste Framework Directive, etc.

Work Environment:

• This is largely a sedentary role.
• This job operates in a professional office environment and routinely uses standard office equipment.
• While performing the duties of this job, the employee may be required to sit or stand for long periods of time.
• Must be able to occasionally move and lift objects of up to 25 lbs.
• Typically requires travel less than 5% of the time.

About Us

ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.

With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.

We\'re ready to bring you consistent quality, innovation, and value in more areas than ever. Our focus allows us to bring you:

Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.

The industry\'s broad