Job details
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
Pay rate will not be below any applicable local minimum wage rates.
