Senior Quality Assurance Inspector 2nd Shift
ICU Medical

Job Description

Position Summary

The Sr Quality Assurance Inspector performs audit review on each batch record to ensure completeness and compliance before final release of products. This audit to assure the product has been manufactured in accordance with established quality standards. Sr. Quality Assurance Inspector is responsible to retain all batch records per retention procedure.

This role is 2nd shift (2:45 pm to 11:15 pm, Monday thru Friday) and is 100% onsite at our Southington, CT location.

Essential Duties & Responsibilities

• Perform audits on each batch record to ensure completion and compliance (in hard copy or electronic version)
• Execute final product release via iFactory / Oracle system
• Access to Oracle Installed Base to update serial device information
• Provides Manufacturing / MQA support to detect quality risks
• Verify that the records documented are within the corresponding procedures
• Demonstrate leadership, problem solving skills and technical knowledge with solid communication skills, attitude, dedication and commitment
• Ensures departmental compliance to all Federal, State, Local and Company regulatory requirements. These elements include FQA, EPA, FDA, OSHA, ISO, EEPC and Company policies relative to the manufacture of product, lot control requirements, documentation requirements, housekeeping, preventative maintenance, calibration, associate training and safety (equipment, associate)
• File and retain batch records in controlled area per retention procedure
• Ability to troubleshoot and work in a team environment
• Other activities related to the position

Knowledge, Skills & Qualifications

• Excellent Mathematical knowledge
• Good knowledge in records filing
• Good computer knowledge
• Ability to comprehend both verbal and written instructions

Education and Experience

• Must be at least 18 years of age
• High School Diploma or GED required
• Experience with medical devices/pharmaceutical GMPs preferred
• Minimum of 2 years in a FDA regulated manufacturing environment

Physical Requirements and Work Environment

• While performing the duties of this job, the employee is regularly required to talk, hear and communicate on phone and through email.
• While performing the duties of this job, the employee is regularly required to sit which is mainly on the computer with some standing during shift
• Must be able to repetitively move and lift objects of up to 20 lbs
• Typically requires travel less than 5% of the time

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 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 humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates.

ICU Medical EEO Policy Statement

Know Your Rights: Workplace Discrimination is Illegal Poster

ICU Medical CCPA Notice to Job Applicants

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