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Job description
Under general supervision, perform repetitive inspections of a routine to moderately complex nature, using measurement and test equipment, following established inspection procedures.
2. Responsibilities and Functions
- Continuously comply with the standards required by ISO, FDA and QSR, following our internal operational policies and procedures.
- Inspect and / or measure raw material components in the receipt phase that have been transferred to the Quality Control area, according to the specifications of their drawings and the instructions and / or established procedures.
- Inspect packaging material and / or labels or product literature to verify regulatory compliance.
- Ensure that the raw material, in process or finished product meets the established standards.
- Stop the flow of material in case of finding any non-conformity in it.
- Initiate the NC (Non Conformance) procedure to report non-conformities found in the inspection process.
- Record and document in the SAP system transactions of the movement of inspected components and the results of the applicable inspections.
- Maintain constant communication with other functional groups to establish inspection priorities.
- Carry out work according to instructions (can be verbal or written)
- Identify the products according to the state in which they are
- Ensure GMP for quality records
3. Educational Level and Special Training Required
- High school completed
- Use of computer systems
- Knowledge of the quality system for medical devices
4. Work Experience Required
1 to 2 years of experience in quality control activities preferably.
- Reading, writing, basic mathematics and basic handling of measurement and test equipment.
- Basic handling of "Blueprint / engineering schematic" (reading and interpretation).
- Basic inspection techniques. (Distance, thickness, height, diameters, force; etc.)
- Read and interpret documents and / or systems written in English.
- Problem-solving and decision-making skills.
- Recognize specifications and units of measurement.
5. Qualifications and Skills
- Observe and notice minor inconsistencies.
- Follow and explain detailed instructions and inspection procedures.
- Complete in detail and accurately all documentation generated in their work.
- Ability to manage systems and navigate through the screens that apply.
- Communicate deficiencies about products, components and / or assemblies to Supervisors or Engineers.
6. Physical Requirements
- Medium work: Exercising up to 50lbs. of force periodically and / or up to 20lbs. of force constantly.
- You must have very sharp vision.
- Ability to work with and inspect small objects and / or tools, parts, components, and assemblies.