Quality Engineer, Medical Devices: Validation & Risk

BD; Innsbruck; Vor Ort; EUR 102.000 - 156.000; Vollzeit

Zusammenfassung

BD is seeking a Quality Engineer for the Medical Devices division in Wangs, Switzerland. You will help establish quality control standards, perform risk assessments, and support validation activities in a multidisciplinary, international team.

The role requires a Bachelor’s in engineering, fluency in German and English, and experience with ISO 13485/14971 and regulatory standards. Expect involvement in CAPAs, DFMEA, and MDR compliance.

Qualifikationen

• Fluent English and German required (written and spoken).
• Bachelor's degree in an engineering discipline relevant to medical devices.
• Working in a regulated medical device environment experience preferred.
• Strong analytical abilities and attention to detail.
• Proficiency with DOE and process validation methods is a plus.

Aufgaben

• Support quality development activities for commercial production.
• Ensure compliance with quality system requirements (ISO, MDR, FDA).
• Collaborate with Manufacturing Engineering on FMEAs and risk management documents.
• Assist in validation and re-validation of test methods and processes.
• Develop, review, and approve validation protocols and reports.
• Support CAPAs and perform root-cause analyses.
• Conduct statistical analyses to assess process capability.
• Participate in regulatory audits as quality expert.

Kenntnisse

Fluent English

Fluent German

Analytical skills

Team collaboration

MS Office

Ausbildung

Bachelor's degree in engineering

Tools

Minitab

Jobbeschreibung

BD is seeking a Quality Engineer for the Medical Devices division in Wangs, Switzerland. You will help establish quality control standards, perform risk assessments, and support validation activities in a multidisciplinary, international team.

The role requires a Bachelor’s in engineering, fluency in German and English, and experience with ISO 13485/14971 and regulatory standards. Expect involvement in CAPAs, DFMEA, and MDR compliance.