MedTech Quality Engineer - Validation & Compliance

BD; Schweiz; Remote; CHF 110,000 - 150,000; Full time

Job summary

BD in Wangs, Switzerland, is seeking a Quality Engineer (m/w/d) to join a highly regulated medical device manufacturing environment. You will support validation, risk management, and quality assurance activities across the product lifecycle.

The role requires hands‑on experience with IQ/OQ/PQ, FMEA, ISO 13485, EU MDR, and CAPA processes, along with fluency in German and English. Collaboration with cross‑functional teams is essential to ensure patient safety and regulatory compliance.

Qualifications

• Bachelor's degree in engineering or related field.
• Experience in the medical device industry or a regulated environment.
• Hands-on experience with validation activities (IQ/OQ/PQ) and CAPA processes.
• Fluent in German and English (written and spoken).
• Knowledge of ISO 13485, ISO 14971/24971 and EU MDR.

Responsibilities

• Support quality development activities for commercial production.
• Ensure compliance with internal procedures, FDA regulations, and ISO 13485/EU MDR/ASTM standards.
• 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.

Skills

German language

English language

Quality engineering

Regulatory compliance

CAPA problem solving

Statistical analysis

MS Office

Minitab

Design of Experiments (DOE)

Risk management

Education

Bachelor's degree in engineering

Tools

Minitab

DOE

Job description

BD in Wangs, Switzerland, is seeking a Quality Engineer (m/w/d) to join a highly regulated medical device manufacturing environment. You will support validation, risk management, and quality assurance activities across the product lifecycle.

The role requires hands‑on experience with IQ/OQ/PQ, FMEA, ISO 13485, EU MDR, and CAPA processes, along with fluency in German and English. Collaboration with cross‑functional teams is essential to ensure patient safety and regulatory compliance.