Quality - Quality Assurance Technician I

Summary

Viant Medical creates life-enhancing medical devices and provides design, development, manufacturing, and assembly services for medical device products. The Quality Assurance Technician I provides quality assurance support across incoming inspection, assembly, manufacturing, and product release, while performing mechanical, electrical, visual, dimensional, and process inspections in compliance with applicable standards and procedures.

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

Skills

• Associates degree or equivalent in work experience
• 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 (1) year of experience as Quality Assurance Inspector
• 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
• 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
• Bachelor Degree in Natural Sciences preferable

Qualifications

Must Haves

• Associates degree or equivalent in work experience
• 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 (1) year of experience as Quality Assurance Inspector
• 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
• 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

Nice to Haves

• Bachelor Degree in Natural Sciences preferable

Benefits

• Medical, dental, and vision benefits—effective on date of hire!
• Shift differential pay
• 401k plan with company match
• Generous paid time off benefits and 10 paid Holidays per calendar year
• Referral Bonus
• Company-paid life insurance
• On-site Training Programs
• Defined Career Path for advancement in role and compensation
• New Hire On-boarding Training Plans