QMS Specialist (MedTech)

TL;DR

QMS Specialist (MedTech): Developing and maintaining the Quality Management System in compliance with MDR and FDA requirements with an accent on document control and audit coordination. Focus on integrating QMS across product design, production, and post-market surveillance to ensure sustained compliance.

Location: Hybrid (3 days in the Vilnius office)

Salary: €2,500–3,500 gross/month

Company

A fast-growing wellness tech company recognized by Deloitte as the #1 Company to Watch in the Technology Fast 50 CE program.

What you will do

• Own and maintain QMS procedures, documents, and records in accordance with MDR and FDA requirements.
• 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, development, production, and post-market surveillance.
• 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 ISO 13485.
• Fluent English required.
• Experience conducting or supporting internal/external audits.
• Proficiency with digital document control platforms.

Nice to have

• Lithuanian language proficiency.
• Certified Quality Auditor credential.
• Understanding of medical device software, hardware, and firmware documentation.

Culture & Benefits

• Private health insurance after 6 months of employment.
• Hybrid work model with 3 days in the Vilnius office.
• Work-from-anywhere flexibility for up to 40 days per year.
• Free lunch 3x/week for the Vilnius team.
• Additional vacation days based on tenure and a birthday day off.
• Company hirify.global device to support your well-being.