Senior QA Inspector

ICU Medical•Southington, CT

9d•Onsite

About The Position

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

Requirements

Excellent Mathematical knowledge
Good knowledge in 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
Minimum of 2 years in a FDA regulated manufacturing environment
Ability to repetitively move and lift objects of up to 20 lbs

Nice To Haves

Experience with medical devices/pharmaceutical GMPs preferred

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