Staff Quality Assurance Engineer

@ Synapse Health

About Synapse Health

With the collective efforts of our epic team members, we’re trailblazing a new path in the DME industry. Founded in 2016, Synapse Health aims to fix the fractured DME ecosystem through tech-based solutions that eliminate age-old headaches and deliver a seamless experience.

Role Overview: Staff Quality Assurance Engineer

The Staff Quality Assurance Engineer leads and elevates quality engineering efforts across products, systems, and processes. This senior role involves driving continuous improvement, mentoring quality engineers, and ensuring compliance with regulatory standards.

Key Responsibilities

• Lead development and execution of quality strategies for products.
• Serve as a subject matter expert for quality systems and best practices.
• Drive root cause analysis and implement corrective and preventive actions.
• Own quality metrics such as defect rates, yield, reliability, and field failure rates.
• Collaborate with Product Development teams to implement Design for Quality and Manufacturability principles.
• Develop and improve Quality Management Systems (e.g., ISO 9001, ISO 13485, AS9100).
• Lead internal and external audits and ensure regulatory compliance.
• Mentor junior quality engineers and cross-functional partners.
• Analyze data trends to identify quality risks or opportunities.
• Work with suppliers to ensure quality of incoming materials and components.

Required Qualifications

• 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 and data analysis techniques.
• Excellent problem-solving and communication skills.

Preferred Qualifications

• Certified Quality Engineer (CQE), Six Sigma Black Belt, or similar.
• Experience in regulated industries such as medical device, aerospace, or automotive.
• Experience with ERP and QMS systems (e.g., SAP, Arena, MasterControl).

Benefits

Synapse Health promotes professional growth and a healthy work-life balance with benefits including paid time off, medical/dental/vision insurance, and a 401K savings plan with match.

Key skills/competency

• Quality Engineering
• Regulatory Compliance
• Root Cause Analysis
• CAPA
• Design for Quality
• ISO Standards
• Mentorship
• Data Analysis
• Auditing
• Supplier Quality