Quality - Quality Assurance Technician I

Hace 3 semanas

Vega Baja, Puerto Rico Viant Medical Jornada completa

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, ISO*, 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 or