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
- English (speaking and writing)
- 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
Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better.
The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.
More information is available at stryker.com