---
title: 'Supplier Quality Engineer at Hyperfine'
canonical: 'https://feeny.ai/job/supplier-quality-engineer-hyperfine-guilford-q1jn5w3zzen8'
type: 'job'
last_seen: '2026-09-11'
---

# Supplier Quality Engineer at Hyperfine

- **Company:** Hyperfine
- **Location:** Guilford, CT
- **Posted:** 2026-07-20
- **Last confirmed live:** 2026-09-11
- **Apply:** https://job-boards.greenhouse.io/hyperfine53/jobs/6119323004

## Job description

## About Us

Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop® system—the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of care in a healthcare facility. Our mission is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging. [Learn More](https://hyperfine.io/)

## About The Role

Job Title: Supplier Quality Engineer

Location: Guilford, CT (Onsite)

## SUMMARY:

Provide leadership, guidance, and analytical expertise to support the robust manufacturing and evaluation of Hyperfine products, ensuring quality standards are achieved, applicable regulatory requirements are maintained, and opportunities for continuous improvement and standardization are realized. Serve as the primary quality representative for suppliers, establishing quality expectations, monitoring supplier performance, and driving the resolution of quality and compliance issues to ensure that products consistently meet Hyperfine’s quality and regulatory requirements.

## RESPONSIBILITIES:

- Establish and maintain Supplier Qualification process and associated documentation, including supplier audits, supplier agreements, the Approved Supplier List, and supplier scorecards.
- Conduct product release activities, including review and approval of Supplier Device History Records (DHRs)
- Collaborate with Operations, Engineering, and R&D to ensure that the products produced meet applicable quality and regulatory requirements, including risk assessment and disposition of deviations, rework activities, Visual Assembly Process (VAP) documentation.
- Analyze supplier quality and internal manufacturing performance metrics to identify trends, drive continuous improvement initiatives, and support process standardization efforts.
- Own and manage Nonconformances (NCs), Corrective and Preventive Actions (CAPAs) and Supplier Corrective Action Requests (SCARs), as assigned
- Support the maintenance of Quality System documentation, as necessary.
- Support and participate in Internal and External Audits, as necessary

## KNOWLEDGE AND SKILL:

- Strong working knowledge of 21 CFR Part 820, ISO 13485, ISO 14971 principles, and applicable medical device regulatory requirements.
- Demonstrated leadership in supplier quality management, supplier audits, Nonconformance and CAPAs/SCARs, and risk management activities.
- Experience planning, conducting, and managing supplier audits, including audit reporting, follow-up, and effectiveness verification.
- Strong analytical and problem-solving skills including Root Cause Analysis, CAPA, Change Management, Risk Management and Six Sigma methodologies, statistical analysis, and data-driven decision making.
- Proficiency with MS Office, ERP systems, and eQMS platforms.
- Ability to communicate effectively and influence stakeholders across all levels of the organization and with external suppliers.
- Strong technical writing, communication, and data analysis skills.

## EDUCATION/EXPERIENCE REQUIRED:

- BA/BS degree in a technical discipline preferred. Equivalent experience may be considered in lieu of higher degree.5 - 7 years of experience in a quality role within a regulated industry, preferably including supplier auditing and supplier management.

## PREFERRED QUALIFICATIONS:

- ASQ Certified Quality Auditor (CQA), Certified Quality Engineer (CQE) or Certified Six Sigma Green Belt (CSSGB)
- ISO 13485 or MDSAP auditor training.

## PHYSICAL DEMANDS:

- Ability to sit, stand, walk, and perform computer-based work for extended periods
- Ability to use standard office equipment, including computers, telephones, printers, and scanners.
- Ability to work in manufacturing, warehouse, and supplier environments while complying with applicable safety and personal protective equipment requirements
- Ability to occasionally lift and carry materials weighing up to 25 pounds.
- Ability to periodically access manufacturing, warehouse, and supplier facilities.
- Ability to travel domestically and internationally, as required. (Up to 15% travel)
- Ability to work additional hours as needed to support audits, supplier activities, and business objectives.

Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship now or in the future of any employment Visa.

Compensation: The annual base salary for this position is between $107,000 - $123,000. This position is also eligible for to participate in Hyperfine's corporate bonus and equity plans. Individual compensation packages are based on various factors unique to each candidate including skill set, relevant experience, qualifications, location, position level, and other job-related reasons.

Agency Resumes: We do not accept resumes from recruitment agencies without a prior agreement in place. Any unsolicited resumes submitted by agencies will be considered the property of Hyperfine and will not be subject to any fees or charges if the candidate is hired.

## About Hyperfine

## Company Overview
- **One-liner**: Hyperfine is a health technology company that developed the Swoop® system, the first FDA-cleared portable, ultra-low-field magnetic resonance brain imaging system designed for use at the point of care.
- **Entity Type**: Public (NASDAQ: HYPR)
- **Headquarters**: Guilford, Connecticut, United States
- **Founded**: 2014
- **Founders**: Jonathan Rothberg, PhD

## Core Business
- **Primary industry**: Medical equipment manufacturing / health technology (portable MRI)
- **Target customers**: B2B – hospitals, neurology practices, pediatric units, ICUs, emergency departments, and other healthcare facilities
- **Mission statement**: “To revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging.”

## Products & Services
- **Swoop® Portable MR Imaging® System**: An ultra-low-field (0.064T) portable MRI scanner that plugs into a standard outlet and can be operated by any trained healthcare professional. It provides diagnostic-quality brain imaging (T1, T2, FLAIR, DWI sequences) in multiple planes, with an open, quiet design that reduces patient anxiety and allows family to stay beside the patient.
- **Optive AI™ Software**: An AI-driven image reconstruction platform that uses deep learning to reduce noise and blur, delivering sharper anatomical detail at lower field strengths to support confident diagnosis at the point of care.

## Market Standing
- **Valuation / Market Cap**: Not publicly disclosed
- **Key Metric**: Annual Revenue: USD $13.6 million (LinkedIn estimate for most recent fiscal year)
- **Total Funding**: USD $454.8 million raised across 10 rounds, including a $207M corporate round (2021), Series D ($90M, 2021), and a $6M post-IPO equity round (2025)
- **Notable Investors / Partners**: HealthCor Catalio Acquisition Corp. (parent company); other investors from Series C, D, and seed rounds (names not fully detailed in available sources)
- **Growth Signals**: Revenue generation at $13.6M; 99 employees with a -10.3% YoY headcount decline; active presence in the US, UK, Italy, and Germany; 9 open job postings as of mid-2026; continued R&D investment in AI and sequence development

## Competitive Advantages
- **Portable & point-of-care**: The only FDA-cleared portable MRI that can be brought to the patient’s bedside without requiring dedicated infrastructure or shielding.
- **AI-powered image quality**: Optive AI software enables clear diagnostic images at 0.064T, a field strength far lower than conventional MRI.
- **Patient-friendly**: Open design, quiet operation, no ionizing radiation, and allows family/caregivers to remain present during scans.
- **Ease of use**: Simple plug-and-play setup; any trained healthcare professional can operate the system.

## Strategic Focus
- **Expand global access**: Address the 80% of the world’s population that lacks MRI access by making imaging affordable and deployable in any care setting.
- **Deepen clinical adoption**: Grow adoption in neurology, pediatrics, ICU, and emergency departments through evidence generation and reimbursement support.
- **Advance AI capabilities**: Continue improving image reconstruction and adding new sequences to enhance diagnostic confidence.

## Why Work Here
- **Mission-driven culture**: Employees are motivated by the goal of democratizing MRI and saving lives through accessible imaging.
- **Cutting-edge technology**: Work at the intersection of MRI physics, deep learning, electrical engineering, and cloud software.
- **Small, impactful team**: With ~99 employees, individuals can have outsized influence on product development and company direction.
- **Open roles**: Active hiring for Senior AI Scientist, Senior Software Engineer (Cloud), Staff Product Manager, Regulatory Affairs, Sales, and more (see careers page).
- **Location & flexibility**: Headquarters in Guilford, CT; presence in the UK, Italy, and Germany; likely hybrid/office model typical of medtech companies.
- **Leadership**: Led by CEO Maria Sainz and a management team with deep medtech and MRI experience; founder Jonathan Rothberg is a serial entrepreneur (also founded Butterfly Network, Quantum-Si).

## Sources
1. [hyperfinemri.com – About Hyperfine](https://www.hyperfinemri.com/about/about-hyperfine)
2. [hyperfinemri.com – Swoop System Overview](https://www.hyperfinemri.com/)
3. [hyperfinemri.com – Careers](https://www.hyperfinemri.com/about/careers)
4. [linkedin.com – Hyperfine Company Page](https://www.linkedin.com/company/hyperfine-inc)
5. [hyperfinemri.com – Management Team](https://www.hyperfinemri.com/about/management-team)

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