Quality - Quality Assurance Technician I

Clear Destination Inc.; Vega Baja, Northern (PR, KY); Hybrid; USD 48,000 - 70,000; Full time

Benefits offered by this job

Medical/dental/vision benefits

Shift differential pay

401k with company match

Paid time off

Holiday pay

Referral bonus

Life insurance

On-site training

Career advancement

New hire onboarding

Job summary

Viant Puerto Rico is seeking a Quality Assurance Technician to support incoming, inspection, sub-assembly, and manufacturing quality. You will perform mechanical, electrical, and visual inspections per Viant documentation, while following GMP, FDA, and ISO13485 standards.

You will work under supervision on semi-structured tasks, contribute to LHR/DHR reviews, train operators, and assist calibration of inspection equipment. A strong QA background in medical devices is preferred.

Qualifications

• Associates degree or equivalent in work experience. Bachelor Degree in Natural Sciences preferable.
• English understanding, Quality oriented and statistical knowledge.

Responsibilities

• Follows all GMPs, SOPs, and regulatory standards to ensure quality.
• Performs incoming inspection and disposition of raw material and components.
• conducts in-process dimensional and visual inspections to ensure customer specs.
• Audit assigned areas and perform basic ERP transactions.
• Manage retains of production and validation projects.
• Perform LHR and DHR reviews and participate in CAPA activities.
• Assist in Gage R&R studies, validation projects, and process capabilities.
• Implement inspection cost-reduction techniques and improve testing methods.
• Train quality inspectors and support calibration of gaging and equipment.
• Report defects and provide feedback to improve product quality.

Skills

Interpret specs

Testing equipment

Technical writing

Statistical knowledge

Analytical skills

Problem solving

Cross-functional teamwork

Multitasking

Microscope adjustment

Quality control

Education

Associates degree

Bachelor degree in Natural Sciences

Tools

Pin gauges

Snap gauges

Micrometer

Caliper

Job description

Quality Assurance Technician

Join a team dedicated to creating life-enhancing medical devices that improve lives around the world. Whether you’re starting your career or bringing prior experience, Viant offers opportunities to learn, grow, and make a meaningful impact. Through our people-first culture and commitment to We’re In It For Life, we support your development, well-being, and long-term success.

Compensation:

We offer market competitive compensation and Career Laddering Opportunities. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

Work Schedule:

We are expanding and have the following shift available: 8 am-4.30 pm.

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

About the role:

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.

Job 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

Job Requirements:

Education:

• Associates degree or equivalent in work experience. Bachelor Degree in Natural Sciences preferable.
• English understanding, Quality oriented and statistical knowledge.

Experience:

• 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

Skills/Competencies:

• 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.

About the site:

At Viant Puerto Rico, every product begins with a disciplined approach toprocess. The team’sexpertisein drug delivery and complex device assembly allows for precise, repeatable performance at scale and the control needed to meet the most demanding regulatory and clinical requirements.

The facilitysupportssterile and non-sterile medical devices across a range of clinical applications. Flexible supply models (make-to-order, Kanban, vendor-managed inventory, and consignment) allow customers to scale production without interruption, too.

Apply today and help us bring life-changing medical technologies to patients worldwide.

About the company:

Viant is a global medical device partner providing design, development, manufacturing, and assembly services through capabilities in materials, plastics, metals, extrusion, and automation. With nearly 6,000 employees across 24 locations worldwide, it delivers high-quality, life-enhancing products with the scale and expertise to bring devices to market efficiently. Learn more at Viant Medical’s website or in LinkedIn.