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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Engineering with a strong focus on managing quality-related processes, conducting root cause analysis, and ensuring compliance with GMP and ISO 13485 standards. Proficient in quality documentation, inspection standards, and continuous improvement initiatives.
Highest-signal resume keywords
Quality Engineering ExperienceRoot Cause AnalysisGMP ComplianceISO 13485 KnowledgeContinuous Improvement Initiatives
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Root Cause AnalysisCAPAProcess Capability AnalysisQuality DocumentationInspection StandardsQuality MetricsProcess ValidationRisk AssessmentChange ControlQuality Management Systems
Soft Skills
Effective CommunicationCollaborationStructured ApproachSolution-Oriented Mindset
Tools & Technologies
Microsoft OfficeAgileWindchillSAP
Industry Keywords
Medical Device IndustryGMP RequirementsQuality StandardsTechnical Discipline
Tech Stack
Tools & technologiesTypeScript
About the role
Key responsibilities & impact- Manage and continuously improve quality-related processes in close collaboration with Production, Engineering, and other departments
- Handle quality deviations, complaints, and CAPA activities, including root cause analysis and sustainable problem resolution
- Support the assessment of nonconforming products and respond to supplier and customer inquiries regarding quality issues
- Participate in process and equipment validations (IQ/OQ/PQ), as well as change controls and risk assessments
- Prepare, maintain, and review quality documentation, inspection standards, and quality metrics
- Support internal and external audits and implement continuous improvement and Lean initiatives
- Ensure compliance with GMP, quality, and regulatory requirements
Requirements
What you’ll need- Bachelor’s degree in Engineering or a comparable technical discipline, or completed technical vocational training (e.g., Polymechanic EFZ) with further education at HF Technician level or higher
- At least 2 years of professional experience in Quality Engineering or a comparable technical quality role, ideally in the medical device industry
- Good knowledge of standard quality methods and problem-solving tools such as Root Cause Analysis, 8D, CAPA, and Process Capability Analysis
- Very good IT user skills, particularly in Microsoft Office; experience with systems such as Agile, Windchill, or SAP is an advantage
- Excellent written and spoken German and English skills
- Knowledge of GMP requirements and quality management systems; experience with ISO 13485 is an advantage
- Ability to collaborate and communicate effectively across functions with Production, Engineering, suppliers, and customers
- Independent, structured, and solution-oriented approach to work
Benefits
Comp & perks- Progressive employment conditions with long-term prospects
- A responsible and varied role in a global company with a strong local presence
- A high degree of ownership and autonomy
- Freedom for creative thinking and personal and professional development
- Attractive bonus program
- Additional vacation days
- Further attractive benefits
- Up to two days of remote work per week by agreement
