Quality Engineer

Quality Engineer Co-Diagnostics Inc. - 2.6 Salt Lake City, UT Job Details Full-time From $80,000 a year 22 hours ago Benefits Health savings account Health insurance Dental insurance 401(k) Flexible spending account Paid time off Employee assistance program Vision insurance 401(k) matching Life insurance Qualifications Teamwork Continuous improvement Attention to detail Quality improvement Manual handling Full Job Description 1. Job purpose Co-Diagnostics Inc. (Co-Dx) is a Salt Lake City-based molecular diagnostics company developing innovative at-home and point-of-care PCR testing solutions. We are seeking a Quality Engineer to support quality assurance and control throughout the product lifecycle. This role focuses on maintaining and improving quality systems to ensure compliance with regulatory, customer, and internal standards. The ideal candidate is detail-oriented and collaborative, driving continuous improvement and supporting the delivery of high-quality products. 2. Duties and responsibilities Assist in developing and maintaining quality control and assurance procedures in compliance with ISO 13485 and FDA regulations. Collaborate with R D, Manufacturing, and Regulatory teams to ensure quality is built into every stage of product development and production. Review product and process specifications to identify quality requirements and risks. Conduct inspections, audits, and validations to ensure compliance with internal and external standards. Investigate product issues and non-conformances; lead root cause analyses and implement corrective and preventive actions (CAPA). Support statistical analysis and trending of quality data; generate reports and recommend improvements. Assist in managing supplier quality, including audits and incoming inspection protocols. Participate in internal and external audits (e.g., ISO, FDA). Review and approve engineering change orders, test protocols, and quality records. Support document control, training, and continuous improvement initiatives. Assist in evaluating customer feedback and implementing quality-related customer satisfaction improvements. Job site and regular attendance is required. 3.

Qualifications Education:

Bachelor's degree in engineering, Life Sciences, or a related technical field required.

Experience and Skills:

2+ years of experience in a Quality Assurance or Quality Engineering role in a regulated industry (medical devices, diagnostics, biotech, etc.). Knowledge of ISO 13485 and

FDA 21 CFR

Part 820 quality system regulations. Familiarity with risk management tools (e.g., FMEA), root cause analysis, and CAPA. Experience with statistical tools and quality metrics (e.g., Minitab, SPC). Strong problem-solving skills and attention to detail. Excellent written and verbal communication skills. Proficient in Microsoft Office Suite; experience with QMS software is a plus. ASQ certification (CQE or similar) preferred but not required. 4. 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 including a traditional workday (8:00 am to 5:00 pm), a 9/8/80 schedule, or other assigned shifts. Remote work is not available for this role. 5. Physical requirements This job requires long periods of sitting, standing, and walking. There will be stooping, bending, and twisting. The work environment may include fluctuations in temperature and/or humidity due to medical device manufacturing processes. Must be able to lift 25-50 pounds occasionally. Requires fine motor coordination and hand 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.

Pay:

From $80,000.00 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

Work Location:

In person