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 Quality Specialist to support and maintain our Quality Management System and ensure compliance with FDA and international regulatory requirements. This position will report to the V.P. of Quality and Regulatory.

The primary responsibilities for this role include the following

• Perform product release activities including quality inspections of the manufacturing line
• Verify quality records are accurate, complete, and inspection-ready
• Support the site-wide training program and maintain training records
• Identify nonconformances
• Support corrective and preventive (CAPA) action plans
• Review DHRs for completeness and compliance
• Investigate manufacturing quality issues and documentation discrepancies
• Provide quality support to Manufacturing, Supply Chain and Engineering teams
• Support internal and external (FDA and MDSAP) audits
• Coordinate calibration of inspection and test equipment
• Perform receiving and inspection activities and assist in First Article Inspections (FAIs)
• Support supplier quality activities and investigations
• Support the maintenance and administration of the eQMS
• Support compliance with FDA 21 CFR Part 820, ISO 13485, and MDSAP requirements

Qualifications

• 2-3 years of Quality Assurance and/or Quality Control experience in medical device manufacturing
• Must have direct experience performing product release, including batch record/traveler reviews and performing receiving inspection activities
• Understand Good Manufacturing Practices (GMPs) for medical device manufacturing
• Proficient in Good Documentation Practices (GDP or ALCOA)
• Experience working within FDA-regulated and ISO 13485 certified medical device manufacturing sites
• Experience with CAPA, nonconformance reports (NCMR), document control, and training systems
• Experience working with electronic Quality Management Systems (eQMS)
• Able to perform basic math
• Experience working with measurement tools such as a caliper, ruler, and weight scale

Preferred Qualifications

• Associate’s degree in Biomedical Engineering, Life Sciences, or related field
• 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 $50,000 to $80,000 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