MedTech Quality Engineer – IQ/OQ/PQ & ISO 13485

BD Mexico; Lavamünd; Hybrid; EUR 101.000 - 138.000; Vollzeit

Zusammenfassung

BD, a global medical technology company, seeks a Quality Engineer (m/w/d) to join the Wangs, Switzerland site, supporting validation, risk management, and quality assurance in a highly regulated environment. You will work on process validation (IQ/OQ/PQ), FMEA, ISO 13485, EU MDR, CAPA, and audits, collaborating with Manufacturing Engineering in cross-functional teams.

Fluent in German and English, you will drive quality improvements and ensure compliance with ISO standards while contributing to

Qualifikationen

• Fluent in German and English (written and spoken).
• Experience in medical device industry or a regulated environment.
• Knowledge of global MedTech standards like ISO 13485, ISO 14971/24971, EU MDR.
• Hands-on validation activities (IQ/OQ/PQ) and CAPA processes.

Aufgaben

• Support quality development activities for commercial production.
• Ensure compliance with internal procedures, FDA regulations, and ISO 13485, EU MDR, ASTM.
• Serve as quality subject matter expert during regulatory and internal audits.
• Support validation and re-validation of test methods and manufacturing processes.
• Develop, review, and approve protocols and reports for test method validation.
• Implement IQ, OQ and PQ process qualification activities.

Kenntnisse

Fluent in German and English

Analytical and problem-solving

High accuracy and process-oriented

Collaborative mindset

Ausbildung

Bachelor's degree in Mechanical, Process, Materials Science, Chemical or Pharmaceutical Engineering

Tools

MS Office

DOE

Minitab

Jobbeschreibung

BD, a global medical technology company, seeks a Quality Engineer (m/w/d) to join the Wangs, Switzerland site, supporting validation, risk management, and quality assurance in a highly regulated environment. You will work on process validation (IQ/OQ/PQ), FMEA, ISO 13485, EU MDR, CAPA, and audits, collaborating with Manufacturing Engineering in cross-functional teams.

Fluent in German and English, you will drive quality improvements and ensure compliance with ISO standards while contributing to