Senior Quality Engineer

Barrington James; Bayern; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

Barrington James is seeking a Senior Quality Engineer to join a medical devices organization focused on wearables and connected health. You will ensure quality and regulatory compliance across the full product lifecycle from design to manufacturing and commercialization.

Collaborate with R&D, Regulatory Affairs, Manufacturing and suppliers to uphold safety and reliability of hardware and software integrated wearable devices, applying ISO 13485 and applicable medical device regulations.

Qualifikationen

• Experience in medical device quality engineering.
• Familiarity with wearables, digital health or connected healthcare.
• Experience with hardware/software integrated products.
• Knowledge of risk management (ISO 14971) and design assurance.

Aufgaben

• Support quality activities throughout product development.
• Manage design controls, risk management and verification/validation.
• Support hardware and software integration within wearable devices.
• Drive CAPA, deviations, change controls and continuous improvement.
• Collaborate with cross-functional engineering and regulatory teams.
• Ensure compliance with ISO 13485, FDA 21 CFR 820 and applicable medical device regulations.

Kenntnisse

Quality engineering

Wearables

Hardware/software integration

ISO 14971 risk management

Jobbeschreibung

Senior Quality Engineer - Wearable Medical Devices

Medical Devices | Wearables | Digital Health | Connected Devices

Are you passionate about developing technology that directly improves patient outcomes?

I am currently supporting an innovative medical device organisation looking for a Senior Quality Engineer with experience in the wearables, connected health, or digital medical device space.

This is an exciting opportunity to join a company developing next-generation healthcare technologies, combining hardware, software, sensors and data-driven solutions to deliver safer and more effective patient care.

The Role

You will play a key role in ensuring the quality and compliance of complex wearable medical devices throughout the product lifecycle - from design and development through to manufacturing and commercialisation.

You will work closely with R&D, Regulatory Affairs, Manufacturing and Supplier teams to ensure products meet the highest standards for safety, performance and reliability.

Key Responsibilities

• Support quality activities throughout medical device product development
• Manage design controls, risk management and verification/validation activities
• Support hardware and software integration activities within wearable devices
• Drive CAPA, deviations, change controls and continuous improvement initiatives
• Collaborate with cross-functional engineering and regulatory teams
• Ensure compliance with ISO 13485, FDA 21 CFR 820 and applicable medical device regulations

Ideal Background

• Medical device quality engineering
• Wearable devices, digital health, patient monitoring or connected healthcare technologies
• Hardware/software integrated products
• Risk management (ISO 14971) and design assurance