Senior Quality Assurance Inspector 2nd Shift

ICU Medical•Southington, CT

2d•Onsite

About The Position

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

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

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