Quality - Quality Assurance Inspector

Viant Medical•Vega Baja, PR

48d

About The Position

The Quality Assurance Inspector l is responsible to provide general quality assurance support in the areas of inspection manufacturing and assembly. Performs mechanical, electrical and visual inspection of manufactured product and/or processes per documentation (drawings, specifications and procedures) and industry standards. Freedom to act, under supervision, in semi-structured assignments that requires adherence to defined procedures and/or specific, detailed instructions with limited originality, Solves problems of limited scope and com complexity. Demonstrates Viant values.

Requirements

Proficient in knowledge of a variety of testing equipment (pin gauges, snap gauges, micrometer, caliper, etc.).
Ability to interpret component specifications, drawings and quality procedures.
Proficient technical writing skills and use of documentation programs (e.g., Office Windows, Excel, Access, PowerPoint, etc.)
Performs basic arithmetic calculations: add, multiply, subtract, and divide in all units of measure using whole numbers, common fractions and decimals.
Requires the ability to adjust a microscope e lens to bring an object into sharp focus.
Light physical activity performing non-strenuous, day-to-day activities of a primarily productive nature.
Moderate lifting (20 lbs.), carrying (10 lbs.), bending, and prolonged sitting.
Manual dexterity sufficient to reach/handle items, work with fingers, and perceive attributes of objects and material. Intensive handwork.
Requires the ability to identify and distinguish colors and shapes.
Associates degree or equivalent in work experience. Bachelor Degree in Natural Sciences preferable. English understanding, quality oriented and statistical knowledge.
3 months to 1 year of recent experience in medical device industry, with experience of different medical products with as molding operator.

Responsibilities

Follows all Good Manufacturing Practices and SOP's as defined by Viant's policies, practices and procedures to ensure that FDA regulations, GMP, ISO13485, and Viant quality standards are met.
Checks material disposition and identification in order to meet GMP regulations.
Inspect and document in-bound raw materials for conformance.
Collects samples at scheduled intervals from each machine.
Perform in process dimensional and visual inspection to assure compliance with customer specification giving appropriate disposition according to Viant's procedures.
Responsible for documentation of (in-process) sampling plan, disposition and inspection results
Perform basic ERP transactions.
Work on validation projects as needed.
Manage retains of production and validation projects.
Audits assigned areas.
Verifies that the process inspections and areas in charge are in conformance with Viant's procedures.
Perform SPC/SQC as a preventive tool using suitable software to assure and maintain compliance with customer requirements and Viant's procedures.
Maintain documentation filling update.
Accurately record information consistent with the department format.
Support the calibration of gaging and equipment
Train operators in products quality requirements.
Report any defect found to Manufacturing and/or Quality Supervisor.
Provide feedback to employees on defects found for ensure quality of our product.
Place non-conforming product on hold and create non-conforming records
Conduct quality inspection on rework product
Follow all departmental procedures with respect to routine daily assignments. All workstation areas will be maintained in a neat and orderly manner.
Ensures efficient material flow, storage of inspected parts, and accurate inventory transactions are maintained with the ERP system.