Job DescriptionEssential 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 and may assist in providing responses to the FDA and other regulatory agencies with respect to medical device compliance.
- Provides compliance guidance concerning development, application, and maintenance of quality standards as related to product development within the quality system.
- Work with cross-functional teams to coordinate product changes.
- Participate in design reviews, test readiness reviews, cross functional teams, risk assessments, design transfers, etc.
- Provide corporate quality support, guidance and direction for brining on-market product issues to closure and escalating to senior management for support as necessary.
- Ensure that potential product and process risks are evaluated, prioritized, and mitigated to continuously improve product quality.
- Utilize a wide variety of data sources including product review, global complaints, manufacturing quality data, etc. Monitor product data to identify statistically significant trends and risks.
- Ensure compliance, alignment and consistency with ICU Medical's quality system.
- Prepare, support and ensure the readiness for any potential internal and/or external audits and inspections.
- Work special projects as assigned
Knowledge & Skills - Expert quality compliance, audit, and investigation skills
- In depth deep and broad knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, Complaints, Document Control, etc.)
- Strong knowledge of medical device standards, including but not limited to:
- In depth experience with and knowledge of FDA, MDR, and other key medical device regulations
- Well-developed ability to take a systems approach and to understand the interaction between components (i.e. hardware, software, consumables
- Proven ability to work closely with engineering and manufacturing team members
Minimum Qualifications, Education & Experience - Must be at least 18 years of age
- Bachelor's degree in engineering (Electrical, Mechanical, Biomedical, Software) from an accredited college or university is required.
- Minimum of 7+ years of experience in R&D or Quality is required
- ASQ CQE or CSQE required or the 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 5% to 10% of the time
About UsICU 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 being an 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, 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 We are committed to providing equal access and opportunities for all candidates.
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