Senior Quality Specialist

Transcend, Inc. is a fast‑growing, Twin Cities‑based medical device company transforming the way people experience sleep therapy. Our flagship travel‑friendly CPAP device—compact enough to fit in the palm of your hand—and our expanding accessory and software ecosystem help people sleep better, travel easier, and live more fully—wherever their journey takes them. We’re profitable, rapidly growing, and scaling our team to meet growing demand with bold, hands‑on leadership.

We are seeking a Senior Quality Specialist to support and maintain our Quality Management System and ensure compliance with FDA and international regulatory requirements. This role is responsible for supporting the Quality Management System (QMS) for Class II medical devices and working cross‑functionally with Manufacturing, Engineering, Supply Chain, and Regulatory Affairs to ensure product quality and regulatory compliance. This position is ideal for candidates who enjoy being hands‑on in manufacturing quality, working in an eQMS, and driving quality system effectiveness.

This position will report to the V.P. of Quality and Regulatory.

The primary responsibilities for this role include the following

• Maintain and administer the electronic Quality Management System (eQMS)
• Support compliance with FDA 21 CFR Part 820, ISO 13485, and MDSAP requirements
• Ensure quality records are accurate, complete, and inspection‑ready
• Manage controlled documents, including SOPs, work instructions, and forms
• Maintain Device Master Records (DMR) and Device History Records (DHR)
• Coordinate employee training and maintain training records
• Initiate and investigate CAPAs and nonconformances
• Perform root cause analysis and support corrective actions
• Monitor trends and support continuous improvement
• Review DHRs for completeness and compliance
• Support product release activities
• Investigate manufacturing quality issues and documentation discrepancies
• Provide quality support to Manufacturing and Engineering teams
• Participate in internal audits and support FDA and MDSAP inspections
• Coordinate calibration of inspection and test equipment
• Support supplier quality activities and investigations

Qualification Requirements

• Bachelor’s degree in Biomedical Engineering, Life Sciences, or related field
• 3–5+ years of Quality Assurance experience in medical device manufacturing
• Experience working within FDA‑regulated and ISO 13485 environments
• Experience with CAPA, nonconformance, document control, and training systems
• Experience working with electronic Quality Management Systems (eQMS)
• Strong analytical, documentation, and problem‑solving skills

Preferred Qualifications

• Experience with CPAP, respiratory, or electro‑mechanical medical devices
• Experience with Grand Avenue Software (strongly preferred)
• Experience supporting FDA inspections or MDSAP audits
• Lead Auditor certification or audit experience
• Experience with supplier quality or calibration systems

Why Join Us

At Transcend, your work directly improves people’s lives. You’ll join a collaborative leadership team, shape our technology roadmap, and help define the future of travel‑friendly sleep therapy. If you want to be part of a fast‑moving environment where your work has real impact, we’d love to meet you.

How to Apply

This is a full‑time, on‑site position in our Fridley, MN office. The expected compensation range for this position is $80,000 to $110,000 depending upon qualifications and experience. Qualified candidates should submit their resume and a cover letter detailing why they are a good fit for the role to