Work Flexibility: Onsite

The aim of this job is to Perform inspection of manufacturing goods during the manufacturing process. Conducts dimensional and electrical inspection of sub-assemblies or final systems assemblies. Interprets prints, manufacturing drawings, diagrams, wire cards and lists in approving or rejecting in-process or final assemblies.

What you will do:

• Perform dimensional and/or visual inspection to blueprint using gauges and other reliant inspection equipment.
• Perform material and component inspections.
• Perform First Article Inspection (FAI) and verify FAI data (incl. statistical analysis) is acceptable.
• Read and inspect to blueprints and/or inspection guide sheets / instructions.
• Perform Document Review, analyze, inspect and archive DHRs (paper-based and/or electronically) in compliance to GMP/GDP requirements prior to release to finished goods.
• Maintain the compliance of the control and measurement equipment base, along with managing their calibration.
• Train staff in the use of control and measurement equipment
• Perform computer system transactions related to router inspections, etc.
• Segregate, quarantine and complete documentation for non-conforming materials when necessary.
• Initiation of quarantine tickets (non-conformance reports)
• Perform disposition tasks in the ERP system.
• Support the achievement of Inspection Teams’ KPI's.
• Support in non-conformance handling and analysis
• Work to forecasts and plans based on Business requirements.
• Processing of changes in relation to test process
• Gauge management , support of gauge validation
• Support in processing deviation reports (non-conformity reports in eCAPA, -D reports to supplier quality , etc.)
• Introduction of new employees for quality standard

Good to have:

• High School Diploma of technical education
• 2+ years of work experience in a similar position (preferred ISO 13485/ cGMP manufacturing environment)
• Ability to read the drawings and specifications exhibited
• High proficiency in the use of all standard inspection equipment including calipers, micrometers, microscope, gages and comparators
• Proficiency in the use of coordinate measuring machines, electrical / visual inspection techniques.
• Proficiency in understanding of Inspection Sampling Plans
• Ability to build proficiency in GD&T (Geometric Dimensioning and Tolerancing)
• Ability to build basic proficiency of FDA CFR 820 and ISO 13485 Regulations
• Preferred ability to lift up to 12 kg an occasional
• English (speaking and writing) as plus

Travel Percentage: 10%