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

Job Info

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Position Summary

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.

ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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