Quality Assurance Engineer

To be considered for this opportunity, candidates must have:

• Medical device industry experience
• ISO 13485 experience
• Quality assurance experience within regulated manufacturing environments

We are seeking a Quality Assurance Engineer to ensure the quality and compliance of advanced video and audio hardware systems. This role will collaborate closely with Engineering and Production teams to verify product performance, support quality system requirements, and drive continuous improvement initiatives.

The ideal candidate will have strong technical troubleshooting capabilities, experience with ISO-regulated environments, and a passion for quality excellence.

• Own Quality Assurance and Quality Control processes
• Perform verification, validation, and qualification testing
• Conduct product inspections and failure analysis
• Utilize laboratory equipment including oscilloscopes, signal analyzers, and signal generators
• Support quality planning, scheduling, and resource allocation
• Lead investigations and resolution of customer and internal quality issues
• Conduct internal and supplier audits
• Support ISO 13485 and ISO 9001 compliance activities
• Perform root cause analysis and corrective action implementation
• Develop and maintain quality policies, procedures, and documentation
• Collaborate with engineering teams to address hardware and software quality concerns

• Bachelor's degree in Quality Engineering, Electrical Engineering, Mechanical Engineering, or related discipline
• 5+ years of quality assurance or quality control experience
• Experience with video/audio hardware systems preferred
• Working knowledge of ISO 13485 and ISO 9001 quality systems
• Experience with testing methodologies and laboratory equipment
• Knowledge of video and audio transmission technologies preferred
• Lean/5S training preferred

Suna Solutions provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Applicants, with criminal histories, are considered in a manner that is consistent with local, state, and federal laws.

Suna Solutions is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Suna Solutions and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired.

Compensation for roles at Suna Solutions varies depending on a wide array of factors including but not limited to the specific client, office or remote location, role, skill set and level of experience. As required by local law, Suna Solutions provides a reasonable pay scale to include the hourly or salary range that Suna Solutions reasonably expects to pay for roles that may be hired in California, Colorado, New York City or Washington as set forth below.