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Job Description
Position Summary
The Quality Control (QC) Engineer is primarily responsible for writing instrument and test method validations, verification protocols, and corresponding reports; coordination of validation activities; implementation of standard test methods to comply with compendial changes, method transfers, cleaning validation, and improved methodology due to new technology or processes. Incumbent will interface with other departments, attend plant meetings, review and develop documents including SOP's, specifications, material testing records and prepare standard test method redlines and associated validation / document change control to ensure compliance and perform other essential duties as required.
The QC Engineer is also responsible for investigating and writing investigation documents for compliance to procedures and coordinating quality system programs and projects to ensure regulatory compliance.
The individual will demonstrate project abilities in proficiency evaluation and certification programs including knowledge of compendial (United States Pharmacopeia (USP) and European Pharmacopeia (EP or Ph. Eur.) terminology and requirements and have exhibited the ability to apply standard principles, methods, and techniques in resolving technical problems. The candidate will be highly organized, critical thinking, energetic individual that has knowledge of global regulatory requirements (FDA, cGMP, PICs, MHRA, Health Canada).
Essential Duties & Responsibilities
Knowledge & Skills
Minimum Qualifications, Education & Experience
Work Environment
About Us
Innovation, Impact, and Purpose.
Find Your Future Here.
We manufacture the critical IV solutions providers count on to deliver consistent, reliable care. Each product we make helps ensure patients receive the therapies they need without disruption.
When you work here, you become part of something bigger—a team dedicated to reliability and innovation. No matter the role, your work directly strengthens the healthcare supply chain and impacts patients nationwide.
We offer opportunities for growth, collaboration, and meaningful contributions, all in pursuit of a mission that truly matters.
Join us and help shape the future of IV solutions.
EEO Statement
Otsuka 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 austinhr@icumed.com. We are committed to providing equal access and opportunities for all candidates.
Otsuka ICU Medical EEO Policy Statement
Know Your Rights : Workplace Discrimination is Illegal Poster
Otsuka ICU Medical CCPA Notice to Job Applicants
Seniority level
Seniority level
Entry level
Employment type
Employment type
Full-time
Job function
Job function
Quality Assurance
Industries
Medical Equipment Manufacturing
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Quality Control Engineer • Austin, TX, US