Job Title: Lead Quality and Regulatory Manager
Location: 18 Tower Office Park, Woburn, MA
Department: Quality management
Reports To: COO
Type: Full-Time
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Company Description
Stemwave is a Medical Device startup with locations in the Seaport and Woburn, MA. We are among the fastest growing orthopedic shockwave devices in the United States and are rapidly innovating our product in effort to reach best-in-class status. Ranked as the 227th fastest growing privately-owned startup in 2023, we are looking to continue expanding our team and increasing our capabilities. We are a young company looking for passionate and driven individuals that are eager to make a difference and looking for growth opportunities. Stemwave is an equal opportunity employer and we welcome applicants from diverse backgrounds.
Learn more: www.stemwave.com
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Position Summary
The QMS Manager will lead the maintenance, improvement, and compliance of our quality management system in alignment with ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory standards. This individual will serve as the internal expert on quality systems, lead audits, manage CAPAs and change controls, and work cross-functionally to embed quality throughout the organization.
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Key Responsibilities
● Own and manage the company’s Quality Management System (QMS), ensuring compliance with ISO 13485, FDA QSR, and international regulatory standards.
● Prepare for and lead internal, customer, and third-party audits (e.g., FDA, notified bodies).
● Oversee document control processes and ensure timely creation, review, approval, and training of SOPs, work instructions, and quality records.
● Manage CAPA, nonconformance, and complaint-handling systems from initiation through closure, ensuring timely investigation and root cause analysis.
● Lead risk management activities, including FMEAs and risk files, in compliance with ISO 14971.
● Support design control and product development teams in aligning documentation with QMS requirements.
● Drive continuous improvement projects within the QMS and quality operations.
● Train staff on QMS processes, procedures, and best practices.
● Work closely with Manufacturing, Engineering, Regulatory, and Customer Service teams to ensure quality is built into every process.
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Qualifications Required:
● Bachelor’s degree in Engineering, Life Sciences, or related field
● 5+ years of experience in quality systems within a medical device company
● Deep knowledge of ISO 13485, 21 CFR Part 820, and applicable global regulations
● Experience leading audits and managing CAPA/NCR/complaints programs
● Strong project management, communication, and organizational skills
● Detail-oriented with a mindset for continuous improvement
Preferred:
● Experience with eQMS systems (e.g., Greenlight Guru, MasterControl, Veeva)
● Familiarity with EU MDR, MDSAP, and international submissions
● Lead Auditor certification or formal audit training
● Experience supporting manufacturing transfer or scale-up
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Why StemWave?
StemWave is the ideal environment for ambitious professionals who thrive on challenge and innovation. We’re looking for someone ready to grow, lead, and build the systems that will take us to the next level. Your work here will not just be about meeting standards—it will be about setting them.
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If you're ready to take on an exciting challenge and be a part of StemWave's growth story, we'd love to hear from you. Join us at StemWave and be part of something extraordinary. Let's revolutionize the future of shockwave therapy together!