Staff Quality Assurance Engineer

Reposted 11 Days Ago
Hiring Remotely in USA
Remote
Senior level
Healthtech
Synapse Health is on a mission to transform the DME industry.
The Role
Responsible for leading quality engineering efforts, driving continuous improvement, mentoring engineers, ensuring compliance, and managing quality metrics and systems.
Summary Generated by Built In

Who We Are

With the collective efforts of our epic team members, we’re trailblazing a new path in the DME industry. Synapse Health was founded in 2016 with a goal to fix the fractured DME ecosystem and completely transform the industry. Built on decades of industry and leadership experience, we’ve launched tech-based solutions that eliminate age-old DME headaches, resulting in a seamless experience for all. We are proud to offer work that matters, on a mission that matters.  

Intrigued? Learn more atSynapseHealth.com and onSynapse Health’s LinkedIn.   

What We Need

We are seeking a Staff Quality Engineer to lead and elevate quality engineering efforts across our products, systems, and processes. This role is responsible for driving continuous improvement, mentoring other quality engineers, and ensuring compliance with regulatory standards. As a senior member of the quality team, you will work cross-functionally with Engineering, Manufacturing, Product, and Operations teams to implement scalable quality systems and influence design for quality.

What You Will Do

  • Lead the development and execution of quality strategies for new and existing products.
  • Act as a subject matter expert (SME) for quality systems, tools, and best practices.
  • Drive root cause analysis and implement effective corrective and preventive actions (CAPA).
  • Own quality metrics such as defect rates, yield, reliability, and field failure rates.
  • Collaborate with Product Development teams to implement Design for Quality (DFQ) and Design for Manufacturability (DFM) principles.
  • Develop and improve Quality Management Systems (QMS) in accordance with industry standards (e.g., ISO 9001, ISO 13485, AS9100).
  • Lead internal and external audits and ensure regulatory compliance.
  • Provide mentoring and guidance to junior quality engineers and cross-functional partners.
  • Analyze data trends and proactively identify areas of quality risk or opportunity.
  • Work with suppliers to ensure quality of incoming materials and components.

What You Have

At Synapse Health we’ve intentionally built a culture of kindness, collaboration, and creativity, and we consider those qualities to be table stakes for any new team member. Additional requirements include:

  • Bachelor’s degree in Engineering, Quality Assurance, or a related field.
  • 8+ years of experience in quality engineering or a related field.
  • Proven experience with root cause analysis tools (e.g., 5 Whys, Fishbone, FMEA, Fault Tree).
  • Strong knowledge of quality standards and regulatory requirements (ISO, FDA, etc.).
  • Experience with statistical process control (SPC) and data analysis techniques.
  • Excellent problem-solving and communication skills.

What Sets You Apart

  • Certified Quality Engineer (CQE), Six Sigma Black Belt, or similar certification.
  • Experience in a regulated industry (e.g., medical device, aerospace, automotive).
  • Hands-on experience with ERP and QMS systems (e.g., SAP, Arena, MasterControl).

What Sets Us Apart

It’s no secret that most of us work to provide for ourselves and those we love, but just because we have to work doesn’t mean we can’t enjoy it. In fact, at Synapse Health, we insist on it! We want our team members to thrive personally and professionally, which is why our benefits include:

  • Professional growth opportunities with compelling career paths
  • Healthy work-life balance culture with paid time off (PTO)
  • Medical, dental, and vision insurance for full-time team members
  • 401K savings plan with employer contribution match

Synapse Health is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

Synapse Health, Inc will never request personal or sensitive information during the recruitment process. Please see our Careers Page for more information to protect yourself from scammers and to learn more about our recruitment process.

Privacy Policy

Top Skills

Arena
As9100
Erp
Iso 13485
Iso 9001
Mastercontrol
Qms
SAP
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The Company
HQ: Skokie, IL
316 Employees
Year Founded: 2016

What We Do

At Synapse Health, we’re on a mission to transform the Durable Medical Equipment (DME) industry with innovative solutions that improve experience, accountability and transparency for all.

Synapse Health is a patient-focused, end-to-end technology-enabled solution that streamlines the entire DME process. We connect all the dots from the time an order is placed to the moment it is delivered to the patient (including administrative tasks like billing). We act as a catalyst for change across the DME ecosystem by connecting patients, prescribers, DME providers and payors, providing a seamless, efficient and positive experience.

Our solutions work in the background to manage every aspect of the DME process, providing real-time, accurate clinical and order information. This allows us to address patient needs faster and ensures orders are accurate and cost-effective. By improving accountability and transparency for all stakeholders, we are enhancing the overall experience. Together with our DME provider and prescriber partners, we provide patients with what they need, when and where they need it, simplifying the process and delivering better outcomes for everyone involved.

Why Work With Us

Our culture is built on a person-first mindset, starting with how we treat our team members and extending to the care we provide. We focus on fostering a warm, supportive environment that values each individual. Our mission-driven approach encourages transformation in healthcare, ensuring patients experience genuine, compassionate care.

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