Job Description
Position Summary
The Quality Systems Engineer II, will support the ICU Quality Engineering Department and report to a Sr. Quality Engineering Manager. The Quality Systems Engineer II is responsible for supporting functional activities associated with deign controls, risk management, and material compliance for medical devices managed under ICU Medical’s Quality Management System. This position will work collaboratively with cross functional groups to ensure effective operation of Design Controls, Risk Management and Material Compliance process. This position will contribute to and, in some cases, lead quality improvements projects. 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:
- Assists with the interpretation and integration of applicable regulations and standards such as: ISO 13485, 21 CFR part 820, MDR 2017/745, MDD 93/42/EEC, ISO 14971.
- Assists in managing restricted substance assessments and evaluating material compliance against industry regulations such as REACH, RoHS, California Prop 65, Conflict Minerals, EU Waste Framework Directive as part of sustaining engineering and new product development.
- Oversees and manages Material Compliance quality process for the company.
- Governs IT Systems processes for material compliance and associated databases.
- Collaborates with teams and other engineers on continuous quality improvement and optimization of the Design Controls, Risk Management, and Material Compliance processes.
- Supports QMS Harmonization initiatives.
- Owns and manages CAPA & NCR tasks and deliverables (Corrective and Preventive).
- Review and revise departmental standard operating procedures.
- Conducts independent analysis and develops solutions to problems.
- Delivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration.
- Long Term Expectations:
- Leads improvements projects and maintains the system to state of the art standards.
- Identify inefficiencies in process workflows and devise appropriate solutions and improvement initiatives.
- Support periodic compliance audits (planned or unplanned).
- Assist with process governance and collaborate with Design, Development and project stakeholders to provide quality technical support.
Knowledge & Skills
- Specific focus on design and maintenance of quality systems to meet regulatory agency expectations and business needs.
- Knowledge of REACH, RoHS, & California Prop 65 regulations.
- 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.
- Computer literate using Microsoft Word, Excel, PowerPoint, and Visio applications.
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 Design Controls and Risk Management of medical devices is required.
- Working experience in material compliance and associated 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.
Salary Range - $71,250 - $102,125
The salary range displayed represents the annual base salary we reasonably expect to pay for this role. The actual salary may vary [differ] based upon various factors, including, but not limited to, relevant experience, skills, education, licensure/certifications, and geographic location.
ICU Medical provides a comprehensive total rewards package that includes:
- Competitive financial benefits, including a generous 401(k) match and (for eligible roles) our Annual Incentive Plan
- A wide range of benefit options at affordable rates
- Additional perks to assist employees with their work-life effectiveness, such as Paid Time Off, Company Holidays, and Tuition Reimbursement
Additional information on health and welfare benefit offerings can be found at https://www.icumed.com/about-us/careers/investing-in-your-future/ .
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
