Quality Assurance Engineer

Overview Spire Therapeutics is seeking a highly motivated Quality Assurance Engineer to support the implementation, maintenance, and scaling of our medical device quality management system and manufacturing operations for our two neuromodulation platforms. This is a hands-on role spanning quality systems, manufacturing process development, risk management, verification testing, and device assembly/documentation. The ideal candidate is comfortable working in a fast-paced startup environment and can operate across both technical engineering and regulated quality/compliance workflows. The role will work closely with engineering, software, clinical, and regulatory teams to ensure our systems are manufactured and documented in compliance with ISO 13485 and

FDA 21 CFR 820

requirements. Responsibilities Support implementation and maintenance of the company's Quality Management System (QMS) under ISO 13485 and

FDA 21 CFR 820

Develop and maintain controlled quality documentation including: DHF, DMR, and manufacturing records SOPs and work instructions Assembly procedures and travelers Training documentation Verification and validation records Assist with supplier qualification, supplier controls, and incoming inspection processes Support manufacturing process development and low-volume in-house production of medical devices Participate in risk management activities including: FMEA Hazard analyses Risk traceability Risk management reports Execute and document device verification and performance testing Assist with software verification and validation activities in coordination with the software engineering team Support CAPA, nonconformance investigations, and root-cause analysis Help establish scalable manufacturing and quality processes as the company grows Maintain organized documentation and revision control practices across engineering and quality systems Required Skills Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Quality Engineering, or related field Strong organizational and technical documentation skills Familiarity with regulated medical device development environments Ability to work independently and manage multiple projects simultaneously Comfortable working in a hands-on startup environment involving both documentation and physical device assembly/testing Preferred Experience Experience with ISO 13485 and/or

FDA 21 CFR 820

quality systems Experience in medical device manufacturing or quality assurance Familiarity with design controls and risk management processes Verification/validation documentation Manufacturing documentation Experience with electromechanical or embedded medical devices Familiarity with software V&V processes Experience supporting FDA audits, supplier management, or CAPA systems Prior experience in neuromodulation, ultrasound, imaging, or other advanced medical technologies is a plus Benefits Competitive salary (~$90,000-$130,000 depending on experience) Direct impact on development of next-generation therapies for brain disorders Fast-moving startup environment with significant technical ownership Opportunity for career growth as the company scales manufacturing and clinical deployment Flexible and collaborative engineering-focused culture Health Insurance Location This position is based onsite in Salt Lake City, Utah. Spire Therapeutics 675 S Arapeen Dr, Suite 301 Salt Lake City, UT 84102

Pay:

$90,000.00 - $130,000.00 per year

Benefits:

401(k) Dental insurance Flexible schedule Health insurance Paid time off

Work Location:

In person