Senior Inspector
ICU Medical, Inc.

Job Info

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Job Title
Sr. QA Inspector

FLSA Status
Non-Exempt

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
• High School Diploma or GED required
• One year previous experience as an MQA or QA Inspector preferred
• Experience with medical devices/pharmaceutical GMPs preferred

Minimum Qualifications
• Must be 18 years of age

Travel Requirements
• Typically requires travel less than 5% of the time

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

ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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