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. This position will be responsible for ensuring that our products and services meet all necessary requirements before they reach the consumer. The Director of Quality oversees the company’s entire quality program to ensure the final products have been built with compliance to legal standards and meets customer expectations.

Duties and responsibilities (Essential Functions)

• Responsible for the development, implementation, and strict adherence to the quality program. Develops and/or reviews standards, policies, and procedures for all functions and departments involved with or related to the production of all products. The Director of Quality has the ultimate authority and decision over the shipment of any product or products and accepts the responsibility for products being in compliance with all regulatory and company standards.
• Reviews and resolves quality control problems/concerns with the Quality Control staff and others including vendors, customers, and any personnel related to production. Coordinates and assists with vendor inspections.
• Periodically inspects completed quality control checklists, forms, and other documents; randomly inspects and verifies quality control checks for conformance to prescribed standards.
• Schedules and performs quality audits and reports findings to the President, and others as may be required; develops corrective action plans and ensures timely resolution of findings.
• Receives and reviews all customer satisfaction surveys and customer contacts and complaints.
• Reviews complaint trends and product/component failure analysis; reviews corrective actions with appropriate personnel.
• Job site and regular attendance is required.

Qualifications (Education, Experience, Skills, Certifications, etc.)

· Master’s or bachelor’s Degree or equivalent, in relevant field, plus 5-10 years or relevant work experience

Note: Assignment or promotion to any level is not guaranteed nor automatic.

• Proven experience as a Quality Manager.
• Experience/Training in ISO:13485.
• Conscientious and responsible.
• A keen eye for detail and a results-driven approach.
• Outstanding communication skills.
• Excellent organizational and leadership skills.
• In-depth understanding of quality control procedures and relevant legal standards.
• Excellent math abilities and working knowledge of data analysis/statistical methods.

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 available for this role (occasional).

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.

• Must be able to lift 50 pounds on a regular basis.
• Fine motor coordination with hand and finger dexterity.
• Good visual acuity including color perception.

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

Job Type: Full-time

Pay: $120,000.00 - $140,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Day shift

Ability to Relocate:

• Salt Lake City, UT 84115: Relocate before starting work (Required)

Work Location: In person