Quality Engineer – Medical Devices, English & German Speaking

Quality Engineer in medical devices at BD, ensuring compliance and supporting cross-functional quality activities. Engaging in test method validation and regulatory audits for quality assurance.

Posted 7/13/2026full-timeWangs • 🇨🇭 SwitzerlandMid-LevelSenior💰 CHF 96,700 - CHF 147,475 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in quality development activities within the medical device industry, ensuring compliance with FDA and international standards while conducting statistical analyses and implementing corrective actions. Proficient in both German and English, with strong analytical skills and a process-oriented mindset.

Highest-signal resume keywords

Quality System ComplianceStatistical AnalysisCorrective/Preventive Actions (CAPAs)FMEA and Risk ManagementFluency in German and English

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality DevelopmentStatistical AnalysisProcess ValidationRoot Cause AnalysisDesign of Experiments (DOE)Process Capability IndicatorsTest Method ValidationProtocol DevelopmentManufacturing Engineering SupportRegulatory Compliance

Soft Skills

Analytical SkillsProcess-Oriented MindsetAttention to Detail

Tools & Technologies

MS OfficeMinitab

Industry Keywords

Medical Device IndustryFDA StandardsISO StandardsMDRASTM

About the role

Key responsibilities & impact

Support all quality development activities for commercial production
Ensure compliance with quality system requirements defined by internal procedures, FDA and international standards (ISO, MDR, ASTM)
Collaborate with Manufacturing Engineering department on FMEAs and risk management documents
Validate test methods and processes, and develop protocols and reports
Support the Manufacturing Engineering team on quality-related tasks and process qualifications/validations
Conduct statistical analyses for process capability indicators
Implement corrective/preventive actions (CAPAs) and perform root cause analyses
Participate in regulatory audits as a quality expert

Requirements

What you’ll need

Bachelor's degree in engineering discipline, preferably mechanical, process, materials science, chemical or pharmaceutical engineering
At least 3 years of experience in medical device industry or similar regulated field
Fluent in German and English, both written and spoken
Good analytical skills, process-oriented mindset, and high level of accuracy
Knowledge of MS Office, especially Word
Familiarity with DOE (Design of Experiments) and statistical software Minitab

Benefits

Comp & perks

Health insurance
Flexible working hours
Professional development opportunities