Specialist II, Quality Systems - Material Compliance - Hybrid
ICU Medical, Inc.

Job Description

The Specialist II, Quality Systems will support functional activities associated with material compliance for medical devices managed under ICU Medical Quality Management System. This position will coordinate, manage, initiate and maintain material compliance and restricted substance assessments for ICU Medical products.

Essential Duties & Responsibilities

• Evaluate material and restricted substance compliance against industry regulations such as REACH, RoHS, California Prop 65, Conflict Minerals, EU Waste Framework Directive, etc. for products going through change management activities.

• Perform initiation and change analyst activities for compliance related work flows for products in Product Lifecycle Management (PLM) IT systems.

• Maintain the material compliance database and certification for impacted products in the PLM systems and EU SCIP.

• Respond to customer inquiries needing inputs for restricted substances.

• Assure accurate and orderly file maintenance of current and historical records.

• Provide support for specification control activities related to purchased products.

• 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 for material compliance and Design Control programs.

• Review and revise departmental operating procedures as required.

• Participate in meetings and activities to support new product introduction or conversions.

• Provide troubleshooting and training support for employees on PLM systems.

• Work on special assignments as they arise.

Knowledge, Skills & Qualifications

• Ability to complete basic projects assigned by senior team members and managers.

• Ability to learn the function and industry best practices.

• Working knowledge of industry compliance regulations such as REACH, RoHS, California Prop 65, Conflict Minerals, EU Waste Framework Directive, etc.

• Knowledge of Design Control concepts for medical devices and quality systems standards such as ISO 13485.

• Product component knowledge preferred.

• Understanding of structure and role of product specifications such as: Commodities, Process Materials, Printed Materials, Commodity and Process Summary and Printed Material Summary preferred.

• Ability to become knowledgeable in departmental procedures, GMP's, Specifications/Guidelines, product lines/processes and commodities.

• Ability to identify inefficiencies and drive improvements in departmental procedures and processes.

• Familiarity with cGMP, FDA, and guidelines governing medical devices.

• Strong verbal and written communication skills.

• Excellent organizational skills.

Education and Experience

• Must be 18 years of age.

• Bachelor's Degree from an accredited college or university (materials science, materials engineering or related disciplines)

• 2 - 4 years of experience in a regulatory, quality or compliance position.

• Working experience in material compliance and associated regulations, in medical device industry. For e.g. REACH, RoHS, California Prop 65, Conflict Minerals, EU Waste Framework Directive, etc.

Physical Requirements and Work Environment

• This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers and filing cabinets.

• 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 pounds.

• 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 broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
• IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
• Significant US IV solutions manufacturing and supply capabilities.

ICU Medical EEO Statement:

ICU Medical is committed to fostering a diverse, inclusive, and equitable work environment. As an Affirmative Action and Equal Opportunity Employer, we ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender identity, gender expression, gender reassignment, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.

If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates.

ICU Medical EEO Policy Statement

OFCCP Equal Opportunity Posters

"Know Your Rights" Poster
Pay Transparency Nondiscrimination Provision

ICU Medical CCPA Notice to Job Applicants

---