QA Inspector - Medical Device Manufacturing

QA Inspector•Medical Device Manufacturing at Cube Hub Inc. QA Inspector•Medical Device Manufacturing at Cube Hub Inc. in Knowlesville, New York Posted in about 24 hours ago.

Type:

full-time

Job Description:

Job Title:

QA Inspector•

Medical Device Manufacturing Description:

Schedule:

Monday•Friday | 5:30 AM•4:30

PM Overtime:

As Needed Location:

(Onsite/Remote)•

Location :

Medina,NY Contract Duration :

6 months

Work Environment:

FDA-Regulated Manufacturing Environment Job Summary The Final QA Inspector is responsible for ensuring final product quality and compliance prior to release. This role performs detailed inspections of Device History Records (DHR), infusion pumps, and wireless battery modules to verify adherence to FDA regulations, cGMP standards, and company quality procedures. The position supports product release activities, nonconformance management, and overall quality assurance operations. Key Responsibilities Perform inspection and review of Device History Records (DHR) in paper format or within the Camstar Manufacturing Execution System. Verify completion of testing procedures and confirm compliance with release specifications. Conduct visual inspection of infusion pumps and wireless battery modules to ensure labeling, appearance, and quality standards are met. Approve product release within ERP systems such as JDE B4ONE and JDE GME. Confirm no open nonconformances exist prior to product release. Review device history logs to ensure final testing is completed according to approved procedures. Document failing observations using rework forms or approved nonconformance systems. Disposition rework activities and complete electronic approval and closure of nonconformances. Ensure adherence to process control and maintenance procedures. Identify out-of-compliance or out-of-tolerance conditions and initiate corrective actions. Inspect service parts and approve final release. Assist in identification, containment, and investigation of nonconforming products. Perform additional duties as assigned. Required Qualifications & Skills Working knowledge of: Measurement and inspection equipment cGMP documentation practices FDA regulations and quality standards Basic ESD (Electrostatic Discharge) requirements Computer-based systems and data entry applications Spreadsheet software Strong attention to detail and accuracy. Ability to perform repetitive hand and finger movements. Strong written and verbal communication skills. Ability to work flexible hours and overtime when required. Ability to visually inspect products, identify particulate or foreign matter, and distinguish colors per FDA requirements. Education & Experience High School Diploma or GED required. Experience in pharmaceutical, medical device, or biotech manufacturing preferred. Familiarity with cGMP and FDA regulatory requirements required. Physical Requirements Ability to sit for extended periods while performing inspections. Ability to stand or walk for long durations as needed. Good hand-eye coordination and manual dexterity. Must be able to lift and carry up to 25 pounds. Ability to push or pull up to 5 pounds over short distances. Work Environment This role operates within an FDA-regulated manufacturing environment with strict quality and safety standards, including: Wearing static protective smock while in production areas. Using ground wrist straps at ESD-sensitive workstations. Working in close proximity to team members. Operating in temperature•and humidity-controlled environments.