Position Summary


Provide quality support for ICU Medical Hardware and Consumable development. The Quality Engineer will support activities such as CAPA investigations, design projects, and will ensure compliance with ICU Medical quality system requirements and applicable regulations and standards, such as ISO 13485, ISO 14971, 21 CFR Part 820, and other applicable regulations and standards.



Essential Duties & Responsibilities


• Effectively utilize quality tools and processes such as product and process controls, risk analysis/management tools, validation, design verification, investigations, CAPA data, etc. to assure product quality.

• Assures conformance with regulations of the FDA and other international regulatory agencies.

• Provides compliance guidance concerning development, application, and maintenance of quality standards as related to product development within the quality system.

• Ensure all Quality attributes for design changes are met.

• Participate in design reviews, test readiness reviews, cross functional teams, risk assessments, design transfers, etc.

• Ensure that potential product and process risks are evaluated, prioritized, and mitigated to continuously improve product quality.

• Support any potential internal and/or external audits and inspections.

• Maintain Design History Files (DHF) up to date as needed.

• Effectively interact with cross-functional team members.

• Provide quality support and for on-market product issues. Bring issues to closure and escalating to management for support as necessary.

• Work special projects as assigned



Knowledge & Skills


• Knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, Complaints, Document Control, etc.)

• Knowledge of medical device standards, ISO 13485, MDSAP, EU MDR and ISO 14971.

• Knowledge in Statistics (Tolerance limits, Cpk, etc.) and Minitab is preferred.



Minimum Qualifications, Education & Experience


• Must be at least 18 years of age

• Bachelor's degree in engineering (Electrical, Mechanical, Biomedical) or related field in engineering from an accredited college or university is required.

• Minimum of 4 years of experience in R&D and/or Quality is required.

• ASQ CQE certification preferred or ability to obtain within one year.



Work Environment


• This is largely a sedentary role.

• This job operates in a professional office environment and routinely uses standard office equipment.

• Typically requires travel less than 5-10% 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.