Quality - Quality Assurance Technician I

JOB DESCRIPTION FORM

Position Title:

Quality Assurance Technician I

Department:

Quality

Labor Category:

  Indirect

  Direct

  Other:

Status:

  Full Time

  Part Time

  Temporary

Position Accountability (employee reports to):

Position reports to the Quality Manager.

Position Description/Responsibilities:

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.

Position Authority:

This position has the authority to accept or reject materials, subassemblies, assemblies and processes that affect the quality and safety of Viant products. This includes the authority to stop production if necessary to assure that nonconforming products are not released for distribution.

Essential Functions:

• 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.

Skills:

• 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.

Physical Requirements:

• 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.
• Well-lighted, air-conditioned, indoor laboratory/production setting with adequate ventilation.

Equipment Used:

• Mechanical and electrical test equipment, calipers, gauges, and standard office computer.

Qualifications:

• Associates degree or equivalent in work experience. Bachelor Degree in Natural Sciences preferable.
• English understanding, Quality oriented and statistical knowledge.
• 4+ years of recent experience in medical device industry, with experience of different medical products with at least one (2) year of experience as Quality Assurance Inspector

Position Approved By

Employee Signature: 

Date: 

Supervisor Signature: 

Date: 

Director of Operations Signature: 

Date: