Quality - Quality Assurance Technician I

Viant•Vega Baja, PR

1d•Onsite

About The Position

The Quality Assurance Technician is responsible to provide general quality assurance support in the areas of incoming, inspection, sub-assembly, Assembly and manufacturing. Performs mechanical, electrical and visual inspection of manufactured product and/or processes per Viant 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 complexity. Demonstrates Viant values.

Requirements

Ability to interpret component specifications, drawings and quality procedures.
Proficient in knowledge of a variety of testing equipment (pin gauges, snap gauges, micrometer, caliper, etc.).
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.
Excellent analytical and written and oral communication skills and the ability to manage a variety of tasks simultaneously within cross-functional teams under minimal day-to-day supervision.
Must be able to identify and recommend effective solutions to problems, utilizing technical problem-solving tools, working individually and with others within and outside the quality function.
Must be able to manage multiple projects and report progress against goals in an objective manner.
Requires the ability to adjust a microscope lens to bring an object into sharp focus.
Manage daily workload under minimal supervision to meet expect personal/department goals.
May help train new employees as required.
Environmental Monitoring knowledge for Quality Systems area as applicable.

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.
Performs incoming inspection and dispositions the raw material, assemblies and components when arrives to our facility according to Viant procedures.
Perform and documents in process dimensional and visual inspection to assure compliance with customer specification giving appropriate disposition according to Viant's procedures.
Audit assigned areas.
Perform basic ERP transactions.
Manage retains of production and validation projects.
Performs LHR and DHR Reviews
Participates in Gage R&R studies, validation projects, process capabilities and/or special test data to validate process, material or molds.
Implements techniques to reduce inspection costs, such as improved inspection methods and aids, automated test equipment, control charting, and efficient application of sampling techniques.
Expert in all inspections, including complex mechanical, optical, or automated systems
Assist quality assurance inspectors training in the area of quality system.
Perform SPC/SQC as a preventive tool using suitable software to assure and maintain compliance with customer requirements and Viant’s procedures.
Accurately record information consistent with the department format.
Support and perform as needed the calibration of gaging and equipment.
Assures that all the inspection equipment is included in the program.
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, create non-conforming records, and review and disposition NCRs.
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.
Support and perform Sterile product release
Support Environmental Monitoring Testing and Analysis
Performance other projects and tasks as assigned.
Performs Non-Viable, Pressure Differentials, Temperature and Humidity Monitoring for all Cleanrooms (Tasks related to Quality Systems area as applicable).
Coordinate with external laboratory Viable and Compress Air testing for cleanrooms (Tasks related to Quality Systems area as applicable).
Coordinate Cleanroom certification with approved supplier to comply with regulation requirements (Tasks related to Quality Systems area as applicable).
Support in the development of action plans to resolve environmental controlled issues that have the potential to impact product quality (Tasks related to Quality Systems area as applicable).
Track and trend laboratory errors and resulting corrective action commitments (Tasks related to Quality Systems area as applicable).
Assist and participate in regulatory internal, customer, ISO and FDA audits/Inspections (Tasks related to Quality Systems area as applicable).
Revise and assist in the development and training on SOP's pertaining to controlled environments and contamination control methods (Tasks related to Quality Systems area as applicable).
Reviews COCs and/or corrects them to comply with product and customer requirements for production shipment (Tasks related to Quality Systems area as applicable).
Support DCO/ECO review to comply with procedures (Task related to Quality Systems area as applicable).