Senior QA Inspector

About the Role

The Final Quality Assurance role performs audit reviews on each batch record to ensure completeness and compliance before the final release of products. This audit assures that the product has been manufactured in accordance with established quality standards. The role is also responsible for retaining all batch records per retention procedures.

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 Oracle Installed Base to update serial device information.
• Provide Manufacturing/MQA support to detect quality risks.
• Verify that records documented are within corresponding procedures.
• Demonstrate leadership, problem-solving skills, and technical knowledge with solid communication skills, attitude, dedication, and commitment.
• Ensure departmental compliance with all Federal, State, Local, and Company regulatory requirements, including FQA, EPA, FDA, OSHA, ISO, EEPC, and Company policies related to product manufacture, lot control, documentation, housekeeping, preventative maintenance, calibration, associate training, and safety.
• File and retain batch records in a controlled area per retention procedure.
• Troubleshoot and work in a team environment.
• Perform other activities related to the position.

Requirements

• Excellent mathematical knowledge.
• Good knowledge of records filing.
• Good computer knowledge.
• Ability to comprehend both verbal and written instructions.
• 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 an FDA-regulated manufacturing environment.

Physical Requirements and Work Environment

• Regularly required to talk, hear, and communicate on the phone and through email.
• Regularly required to sit, mainly working on a computer, with some standing during the 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 consistently provides 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.

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, and significant US IV solutions manufacturing and supply capabilities.