Incoming Quality Technician III

Otsuka ICU Med · Austin

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Position Summary 

The Sr. Incoming Quality (IQ) Tech will be primarily responsible for data verification, technician training, project coordination, and leading or participating in departmental/plant projects that improve efficiency or support manufacturing. The Sr. IQ Tech will serve as a primary or key subject matter expert (SME) during internal and external audits.

The person(s) in this role ensures timely testing of commodities per applicable specifications for use in manufacturing through the scheduling of IQ technicians, the review of sampling plans, commodity testing as needed, and the documentation of IQ investigations.

Essential Duties & Responsibilities

• Manage workload demands to ensure the timely flow of production material through technician scheduling of testing and material sampling. 
• Document non-conforming material results through the use of laboratory investigations. Assist in the generation of Supplier Corrective Action Requests (SCARs).
• Train incoming quality technicians as needed or directed.
• Perform the function of the IQ records coordinator: Ensure area documentation is generated, filed, and stored according to department standards. 
• Ensure material release against required specification requirements. Perform data verification by reviewing completed testing documentation against applicable specifications to ensure proper documentation of all testing performed by IQ Technicians.
• Assist with validation of new instrumentation and/or software updates.
• Perform measurements using various laboratory tools including calipers, rulers, instrumentation, etc.
• Adhere to cGMP's, SOP's and plant policies/guidelines.
• Work effectively to resolve issues with documentation provided by suppliers.
• Maintain all Incoming Quality training modules. Act as Qualified Fellow Employee (QFE) and perform periodic reviews and updates to training materials and Standard Operating Procedures (SOPs).
• Perform special testing (TSR’s), special projects, operate laboratory equipment.
• Perform other duties as assigned or required.

Knowledge & Skills

• Must demonstrate and promote teamwork within the department.
• Excellent communication skills.
• Must have strong verbal/written communication skills and communicate effectively with personnel within the incoming department, outside of the incoming quality department, and various levels of management.
• Must be able to give direction to other technicians in the lab.
• Must be able to interpret controlled drawings and specifications and have a strong understanding of measurement techniques.
• Must have good basic math skills (addition/subtraction/multiplication, significant figures, basic algebra, and working knowledge of the metric system). 
• Must have basic computer skills: e.g. Microsoft office tools such as Word, Excel and Outlook
• Must work well with others to solve problems and handle unexpected assignments, troubleshoot and assist other technicians with equipment problems.
• Must be able to manage workload demands, handle identified issues and prioritize accordingly. 
• Must demonstrate the use of logic to solve routine problems. 
• Successful completion of a cognitive ability test required.
• Must be able to interpret and understand specifications and sampling plans
• Must be able to organize their work and handle multiple tasks simultaneously
• Must use logic to solve routine problems.     
• Must use mechanical aptitude and have reasonable dexterity to operate various testing devices. 
• Effectively use strong understanding of measurement techniques and excellent documentation skills

Minimum Qualifications, Education & Experience 

• Must be at least 18 years of age
• High School Diploma required
• Preferred: Five (5) years of related lab experience. Two (2) years of physical internal laboratory testing experience. (Previous experience in IQ also preferred).

Work Environment

• Performs inspection of raw materials visually, dimensionally, and functionally to ensure compliance to approved specifications. Failure to meet specifications may delay manufacturing of product.
• Physical lab environment involving working with some potentially hazardous materials. 
• Must be able to wear appropriate PPE. 
• Will need to be able to wear a respirator and personal protective equipment during sampling. Mechanical aptitude and reasonable dexterity is required to operate various testing devices. 
• Frequent lifting of light to moderate loads. 
• Must be able to lift/manipulate up to 35 lbs. with minimal assistance.
• This job operates in a professional office environment and routinely uses standard office equipment.

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.

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