Total Quality Senior Specialist contributes to the development, implementation, administration and measurement of total quality management programs, including Six Sigma initiatives. Provides expertise to cross functional teams to facilitate total quality methods, training, tool development, and logistical support. Being a Total Quality Senior Specialist coordinates with production, operations, customer service and other functions to implement programs. Typically requires a bachelor's degree. Additionally, Total Quality Senior Specialist typically reports to a manager. The Total Quality Senior Specialist work is highly independent. May assume a team lead role for the work group. A specialist on complex technical and business matters. To be a Total Quality Senior Specialist typically requires 7+ years of related experience. (Copyright 2024 Salary.com)
Job purpose
Co-Diagnostics Inc, (Co-Dx) is a Salt Lake City molecular diagnostics company committed to finding innovative diagnostic solutions to global health problems as we develop an at-home and point-of-care PCR test platform to detect viruses and other pathogens. The Quality Specialist will execute tasks related to regulatory and quality system functions, as well as participate in product development and operational tasks. Functions include QA support for document control and change control, with additional tasks including deviations, investigations, training, internal audits, Nonconformances and CAPAs.
Duties and responsibilities
· Execute incoming inspection of raw materials, oversee in-process and final product QC.
· Collaborate cross-functionally with operational teams to scale and drive efficiencies in our system.
· Identify and resolve workflow and production issues. Perform regular internal audits to ensure standards and safety regulations are observed.
· Address and discuss issues and proposed solutions.
· Prepare, implement, and enforce QA policies and procedures.
· Will also participate in other Quality and/or Regulatory related efforts as appropriate.
Qualifications
· Bachelor’s Degree or equivalent, plus 1 years of work experience working with diverse teams and writing/preparing documents (some waived with academic experience)
· 1 year laboratory experience preferred - using pipettes, running PCR, and data collection/analysis
· Experience with project management, expectations management, and stakeholder communication is preferred, but not required
· Experience with a technical domain, especially with precise volumetric measurements, mechanical drawing interpretation, data collection and analysis are desired, but not required
Note: Assignment or promotion to any level is not guaranteed nor automatic.
· Ability to foster beneficial relationships with key stakeholders.
· Exceptional analytical and problem-solving skills, and experience applying these skills to resolve issues with a team.
· Ability to work with multidisciplinary teams effectively and show willingness to ask for help.
· Ability to successfully manage multiple competing priorities and projects.
· Superb attention to detail and able to deliver results in a fast paced and dynamic environment.
Working conditions
· May be required to wear PPE such as lab coat, safety glasses and/or face shields, safety gloves, and other safety equipment as needed.
· May work a variety of shifts that include a traditional workday (8:00 am to 5:00 pm, etc.), a 9/8/80 schedule with every other Friday off, or other shifts as may be assigned.
· Remote work is not available for this role.
· Travel on an occasional basis may be required (20-30) to visit all company locations.
Physical requirements
· This job requires long periods of sitting, standing, and walking.
· There will be stooping, bending, and twisting.
· Based on the nature of the medical devices being manufactured, the ambient air temperature and/or humidity levels may fluctuate.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.
Our EEO Policy
Co-Diagnostics is an equal opportunity employer (M/F/D/V). We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, disability, veteran status, or any other basis protected by applicable federal, state, or local law.
Co-Diagnostics participates in E-Verify. No immigration-related sponsorships are available.
Job Type: Full-time
Pay: $27.00 - $32.00 per hour
Benefits:
Experience level:
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Ability to Relocate:
Work Location: In person
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