Quality Specialist – QMS & Documentation, Biotech

Securecell AG; Zürich; Hybrid; CHF 90,000 - 130,000; Full time

Benefits offered by this job

On-site at Urdorf location

Hybrid work options

Public transport nearby

Private accident insurance

Job summary

Securecell AG in Urdorf, Switzerland, seeks a Quality Specialist (60-100%) to join the QA & Regulatory Affairs team. You will ensure quality, compliance, traceability, and accessibility of documentation across the product lifecycle, collaborating with Engineering, Operations and Project Management to deliver high-quality biotech and medical technology solutions worldwide.

The role focuses on creating, maintaining, and controlling quality documentation, supporting inspections and records, and

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Biotechnology or related technical discipline.
• Minimum 4 years of professional experience in Quality Assurance, Quality Control, Documentation Control, or Technical Writing within a regulated industry
• Experience working in Biotechnology, Medical Devices, Pharmaceuticals, or other highly regulated environments
• Proven experience creating, reviewing, and maintaining controlled documentation within a QMS environment
• Familiarity with quality inspection activities, in-process controls, and testing documentation
• Strong technical writing and documentation management skills
• Excellent organizational skills with a high level of attention to detail and accuracy
• Strong knowledge of Microsoft Office and modern document management tools
• Ability to work effectively with multidisciplinary teams and manage multiple priorities simultaneously
• Excellent written and spoken English; German is an advantage
• Availability to work primarily on-site to support production, project teams, and quality activities
• Swiss work authorization or eligibility to work in Switzerland
• We accept direct applications only (no agency submissions)

Responsibilities

• Organize, coordinate, and manage project-related documentation throughout its lifecycle, including review, release, publication, and archiving
• Perform Incoming Quality Inspections, in-process controls, and Factory Acceptance Tests (FAT) according to approved procedures and specifications
• Create, review, and maintain Quality Management System (QMS) documentation and project-specific quality records
• Gather, compile, and consolidate technical information by collaborating with cross-functional teams, suppliers, subject matter experts, and external partners
• Support the preparation and maintenance of technical documentation, including work instructions, operating manuals, test plans, reports, and technical files
• Ensure project and quality documentation is accurate, compliant, and readily retrievable in both electronic and paper formats
• Contribute to the continuous improvement of documentation processes, tools, and quality-related practices
• Proactively communicate potential issues, deviations, and documentation gaps to project leaders and line management
• Provide administrative and documentation support to project and quality teams as required
• Collaborate closely with Production, Project Management, Systems Engineering, and other stakeholders to ensure quality and compliance objectives are achieved
• Support quality assurance activities and continuous improvement initiatives across the organization

Skills

English

German

Cross-functional collaboration

QA documentation

Technical writing

MS Office

Document management tools

Education

Bachelor’s degree in Engineering / Life Sciences / Biotechnology

Tools

MS Office

Document management tools

Job description

Securecell AG in Urdorf, Switzerland, seeks a Quality Specialist (60-100%) to join the QA & Regulatory Affairs team. You will ensure quality, compliance, traceability, and accessibility of documentation across the product lifecycle, collaborating with Engineering, Operations and Project Management to deliver high-quality biotech and medical technology solutions worldwide.

The role focuses on creating, maintaining, and controlling quality documentation, supporting inspections and records, and