Senior QA Inspector

ICU Medical, Inc.; Southington (CT); On-site; USD 55,000 - 75,000; Full time

Job summary

ICU Medical, Inc. is seeking a Final Quality Assurance professional to audit batch records for completeness and regulatory compliance before final product release. You will perform audits in both hard copy or electronic formats and retain batch records per retention procedures.

The role supports manufacturing quality and risk detection, working with various teams to ensure records meet FDA, ISO, and company policy requirements. Travel and shifting may be involved.

Qualifications

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

Responsibilities

• Perform audits on each batch record to ensure completion and compliance.
• Execute final product release via iFactory / Oracle system.
• Access to Oracle Installed Base to update serial device information.
• Provide 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 strong communication.

Skills

Mathematical knowledge

Records filing

Computer literacy

Verbal & written communication

Education

High School Diploma or GED

Tools

Oracle

iFactory

Job description

Position Summary

The Final Quality Assurance 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. Final Quality Assurance is responsible to retain all batch records per retention procedure.

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