Quality Assurance Inspector
Perform receiving inspection of incoming components/materials per applicable specifications and standard operating procedures. Ensure timely release of incoming components/materials, in process production, and finished product to support Manufacturing Operations. Perform additional inspection tasks such as first article inspections and RMA evaluations. Work with Purchasing and Quality Assurance Engineering to ensure suppliers are providing quality products , i.e. implement quality at the source. Work with Quality Assurance and/or Manufacturing Engineering to lead product and process improvements.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Inspects, audits, and reports on components/materials using variable or attribute measuring instruments and techniques to ensure conformance with company’s specifications and quality standards.
• Initiate reject reports for non-conforming product and report non-conforming product to the appropriate Material Review Board.
• Create and/or maintain data records and files of inspected components/materials.
• Create and/or maintain documented procedures in accordance with company’s Quality System.
• Complete accurate incoming inspection transactions in company’s computerized inventory control system.
• Complete first article inspections per applicable standard operating procedures and analyze data.
• Approves finished products by confirming specification and conducting visual inspection.
• Evaluate RMA items and returning product for rework.
• Develop inspection methods and write procedures for inspection methods.
• When necessary conduct periodic sampling of water system and pyrogen testing per applicable standard operating procedures.
• When necessary provide support to quality engineering activities/projects.
• Look for opportunities to improve materials, processes, and products and lead improvement efforts.
QUALIFICATIONS REQUIRED FOR POSITION:
• Must be a high school graduate, with minimum of 3 years quality assurance experience.
• Must be able to use a full complement of standard inspection equipment and basic hand tools, i.e. calipers, micrometers, steel rules, pin gages, go-no-go gages.
• Must be able to perform basic math functions, and possess basic PC skills - including working with spreadsheets/databases and editing documents/procedures.
• Must be able to read and understand engineering drawings, specifications and sampling techniques as well as safety information.
• Familiarity with regulated environments esp. ISO 13485, FDA Quality System Regulations, Good Manufacturing Practices, and Good Laboratory Practices is preferred.
• ASQ Quality Inspection Certification is preferred.
• This position requires that work be performed in warehouse, office, and controlled environment areas. Individual must be able to work indoors in high temperatures/humidity, especially during the summer months. This position may involve exposure to moving machinery, lift trucks, and hazardous substances in the warehouse area.
• Individual must be able to walk, stand, reach both above and below shoulder height, and pull, push or lift up to 50 pounds. Occasional bending, stooping, and crouching is required. This position requires frequent repetitive movement of both hands (firm or fine grasping) and good hearing, vision and color distinction.
IDEAL CANDIDATE PROFILE:
• Must be highly organized and have the ability to manage multiple tasks/projects concurrently.
• Must possess good written and verbal communication skills as well as team building skills and exceptional customer service.
• Must be self-motivated.