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Quality Systems Specialist

Distalmotion SA

# Quality Systems Specialist

> Distalmotion SA · Épalinges, Switzerland · Full-time · Posted 2026-11-14

**Workplace:** on_site

**Department:** Quality Assurance

## Description

The Quality Systems Specialist is responsible for the development, structure, maintenance, and improvements of the Quality Management System.

**Tasks**

**Tasks:**

  • Lead identification, development, architecture, and optimizations of the Quality Management System, at both Global and Site levels.
  • Work collaboratively and support process owners in reviewing, structuring, and documenting their functional new or improved processes.  Structure and integrate multi-referential in the same management system such as IT management system Business Continuity Management system, EHS, finance.
  • Author procedures, policies, work instructions, and related documents with style, content, and format guidelines in compliance with ISO 13485, 21CFR820, EU MDR, MDSAP and other applicable regulations.
  • Actively monitor effectiveness of the quality management system and propose and execute improvement projects.
  • Lead complex quality initiatives (e.g. CAPA, process improvements, new processes, gap analyses, system integrations), make recommendations, develop and execute plans.
  • Plan and conduct internal audits by participating and leading internal audits, follow up on the findings with auditee through effective closure, and present the data for trending.
  • Support electronic QMS transition and take ownership of the software tools including QMS documentation and change control.
  • Support Operational Quality with the handling of non-conformities, tool activities approvals, finish product release.

## Requirements

**Required abilities****:**

  • Degree in Engineering, Scientific
  • 5+ years of quality-related system experience in a medical device company developing medical devices
  • Excellent technical writing, proofing, and language (grammar and spelling) skills with strict attention to details
  • Significant knowledge of medical device Quality Management Systems (ISO 13485, 21 CFR 820) and regulatory landscape (i.e. MDR)
  • Certified lead auditor for ISO 13485
  • Knowledge in certification 27001 is a plus
  • Excellent communication skills and interpersonal relationship skills
  • Advanced problem-solving, organizational, analytical and critical thinking skills
  • Electronic QMS experience is preferred
  • Fluency in English is a must

## Benefits

**What we offer****:**

  • A dynamic, innovative environment with cutting-edge medical technology that is shaping the future of robotic surgery.
  • Fast-growing Company where innovation meets agility.
  • Structured onboarding program and training, ensuring a confident start.
  • High degree of autonomy and flexibility.

## Apply

[Apply at Distalmotion SA](https://apply.workable.com/distalmotion/j/1B7B5E56CB/apply)

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