QMS Specialist

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.

• 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

• 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
• Fluent English required; Lithuanian a plus

Nice to have

• An understanding of medical device software, hardware, and firmware documentation is a plus

• 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.