QMS Specialist
Join Pulsetto as QMS Specialist: own our MDR/FDA QMS, lead audits and CAPAs, and train teams — help safeguard global wellness with a collaborative, diverse team.
About Pulsetto
Pulsetto is one of the fastest-growing wellness tech companies - in 2025 we were officially recognised by Deloitte as the #1 Company to Watch in the Technology Fast 50 CE program.
You may have also seen us on Netflix’s “Don’t Die”, our founder’s Shark Tank pitch 🦈, or even heard that Cristiano Ronaldo and top NBA players use Pulsetto for recovery.
Despite the spotlight, we’re a humble team, moving fast, iterating even faster, and building the future of nervous system wellness. And now we’re expanding our team to power the next stage of global growth.
About The Role
Pulsetto Medical is looking for a QMS Specialist to develop, maintain, and continuously improve our Quality Management System in compliance with MDR (Class IIa) and FDA (Class II) medical device requirements. This role spans the full product lifecycle — from design and development through production and post-market surveillance.
Key Responsibilities
Serve as a key owner of the Pulsetto Medical QMS
Develop and maintain QMS procedures, documents, and records in accordance with MDR and FDA requirements, including document control and archiving
Plan and coordinate internal and external audits, including supplier and subcontractor audits
Organize and deliver QMS/SOP training for internal teams
Administer quality metrics, CAPA processes, quality plans, and spreadsheet validation
Support QMS integration across product design and development, production, and post-market surveillance activities
Manage key stakeholders and coordinate across interdisciplinary teams
Requirements
Bachelor's degree in Engineering, Chemistry, Life Sciences, or a related field
Minimum 2 years of hands-on experience with ISO 13485
Experience with medical device quality system requirements under 21 CFR 820 and/or ISO 13485 preferred
Experience conducting or supporting internal/external audits; Certified Quality Auditor credential a plus
Solid understanding of FDA and ISO medical device quality system requirements
Basic technical writing skills
Proficiency with digital document control platforms
An understanding of medical device software, hardware, and firmware documentation is a plus
Fluent English required; Lithuanian a plus
What Success Looks Like in This Role
Sustained compliance with ISO 13485 and 21 CFR 820
A proactive approach to generating deliverables
Successful audit outcomes
Timely execution of CRs, CAPAs, and resolved NCs
Timely service wheel maintenance
What We Offer
Private health insurance after 6 months.
Hybrid model — 3 days in the Vilnius office.
Work-from-anywhere flexibility: Ability to work from anywhere in the world for up to 40 days per year.
Opportunity to directly influence brand trust and organic growth at a global scale.
Collaboration with a world-class team across Europe and the US.
Office perks — free lunch 3x/week for the Vilnius team.
Additional vacation days based on tenure.
Birthday day off.
Pulsetto device to support your well-being.
A fast-growing, supportive environment where experimentation is the norm.
Location: Vilnius / Hybrid / Remote
Employment Type: Full-time
Salary: €2,500–3,500 gross/month
- Department
- Clinical
About Pulsetto
Pulsetto is redefining wellness with technology that calms the body and empowers the mind. Through vagus nerve stimulation, our device helps people reduce stress, sleep better, and strengthen both physical and mental health—naturally and effortlessly.
Featured on Netflix, trusted by Cristiano Ronaldo and Domantas Sabonis, and loved by 100,000+ users worldwide, Pulsetto is shaping the future of wellness.