Senior QA Inspector
ICU Medical · Southington, CT, United States ·
- Work mode
- Onsite
- Seniority
- Senior
- Category
- QA
Performs final quality audits on medical device batch records to ensure compliance with FDA and GMP standards before product release.
Position Summary
The Sr. QA Inspector performs testing and inspection of sub-assemblies, final product, commodities, GMP, BOP, safety compliance audits. The Sr. QA Inspector enforces GMP compliance as outlined in internal BOPs. The individual is primarily responsible for testing, inspection and release of product and product components and commodities. The individual records and reports results to provide information necessary to assure that product has been manufactured in accordance with established quality standards.
Essential Duties & Responsibilities
- Initiate change requests, BOPs, EPWOs, deviations, NCMRs
- Close-out audit work orders and commodity release
- Complete product and part inspection
- Complete sample pulling
- Complete labeling inspection and control
- Provide line clearance approval
- Monitor GMP practice
- Quarantine and release quarantined materials
- Train new employees and team on GMP and BOPs
- Must perform defect tracking, monthly reporting and data entry
- Complete test requests
- Ensures departmental compliance to all Federal, State, Local and Company regulatory requirements. These elements include FDA, EPA, OSHA, ISO, EEOC and Company policies relative to the manufacture of product, lot control requirements, documentation requirements, housekeeping, preventative maintenance, calibration, associate training and safety (equipment, associate and material).
- Perform these and other duties as necessary or required, the inclusion of which will not alter the basic scope of the position
- Work on special projects as they arise
- Actively demonstrating support through interactions with solid communication skills, attitude, dedication, commitment, respect, pride and trust.
Knowledge, Skills & Qualifications
- Excellent Mathematical knowledge
Education and Experience
- Must be 18 years of age
- High School Diploma or GED required
- Four years previous experience as an MQA or QA Inspector preferred
- Experience with medical devices/pharmaceutical GMPs preferred
Physical Requirements and Work Environment
- While performing the duties of this job, the employee is regularly required to talk or hear.
- This job operates in a clean room environment.
- While performing the duties of this job, the employee may be required to sit or stand for the duration of 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