Senior Quality Assurance Inspector 2nd Shift
ICU Medical · US
Position Summary The Sr Quality Assurance Inspector performs audit review on each batch record to ensure completeness and compliance before final release of...
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, E...