Quality Assurance Technician

At SpectraWAVE, our mission is bold yet simple: to provide unrivaled optical and computational insights to improve the treatment and outcomes for patients with coronary artery disease (CAD) the leading cause of death worldwide. Our FDA-cleared HyperVue™ Imaging System integrates DeepOCT™, near-infrared spectroscopy (NIRS), and advanced machine learning to give interventional cardiologists real-time clarity inside the artery, where it matters most.

SpectraWAVE recently received FDA 510(k) clearance for X1-FFR, an AI-enabled, wire free, drug-free, single angiogram physiology solution that delivers powerful insights without disrupting workflow. Together, HyperVue™ and X1-FFR represent a new era of precision and simplicity in coronary imaging and physiology. 

Backed by Johnson & Johnson Innovation – JJDC, Inc. and other leading MedTech investors, SpectraWAVE recently completed a $50M Series B funding round to accelerate commercialization and product innovation.

We’re a fast-growing, collaborative team united by the belief that technology can save lives. If you’re inspired by innovation, energized by challenge, and ready to make a measurable impact on patient outcomes, we’d love to meet you. 

The QA Technician ensures product quality by performing inspections, testing, and documentation reviews in compliance with regulatory standards.  This role supports manufacturing and quality teams by identifying issues and maintaining accurate records. The technician assists in investigations, audits, and continuous improvement initiatives. Familiarity with GMP, ISO standards, and attention to detail are essential. This individual, under direct supervision, will work with complex electromechanical medical devices that include software and sterile, single-use disposables.

 Key Responsibilities:

• Inspect material, sub-assemblies and finished devices at receiving, in-process and before transfer to finished goods or distribution and maintain records associated with acceptance activities.
• Responsible for proper segregation and quarantine of suspect material and maintaining records associated with these activities.
• Ensure good manufacturing practices and good documentation practices in the manufacturing area.
• Administer equipment calibration and equipment PM process and manage associated records.
• Maintain accurate and timely records and documentation for all assigned activities as required.
• Maintain work area and equipment in a clean and orderly condition and follow prescribed safety regulations.
• Perform other duties at company's direction, as needed.

Minimum Qualifications

• High school diploma
• 3-5 years of experience working in manufacturing, or QC, or engineering environments within a regulated industry (medical device, pharma, biotech, defense, space).
• Ability to manage multiple priorities is a must.
• Must be a self-starter and a fast learner.
• Must work efficiently, both independently and within a team environment.
• Must have good problem-solving skills and great attention to details.
• Excellent written and verbal communication skills required.
• Basic computer skills are necessary
• Excellent written and verbal communication skills.
• Communication, organizational, and critical thinking skills.
• Ability to track and manage multiple projects and deadlines.
• Results oriented.

Desired Qualifications

• Associate or bachelor's degree in science or engineering or relevant field.
• Medical device industry experience
• Cleanroom manufacturing experience
• Experience working with inspection and test equipment including digital multimeters, micrometer, digital drop indicator, calipers, and oscilloscopes
• Prior knowledge of auditing manufacturing and acceptance activities