Snr Design Quality Engineer

Roc Search Europe Limited; England; Hybrid; GBP 55,000 - 65,000; Full time

Job summary

A leading medical device company is seeking a Senior Quality Engineer to drive product and process quality from concept to launch. This hybrid role in the South East will allow you to leverage your expertise in regulatory compliance and risk management, contributing to meaningful product innovations in a collaborative environment.

Qualifications

• 5+ years' experience in Quality within medical devices.
• Knowledge of global quality standards.
• ASQ CQE preferred or willingness to obtain.

Responsibilities

• Support product development and change control activities.
• Ensure compliance with global standards.
• Act as Quality representative across cross-functional teams.

Skills

Risk management

Design controls

CAPA

Education

Degree in Engineering or Life Sciences

Tools

ISO 13485

ISO 14971

FDA QSRs

Job description

Senior Quality Engineer - Medical Devices
Hybrid South East / Home Counties Circa 60,000 + Benefits
A leading medical device company is seeking a Senior Quality Engineer to support product development and change control activities. This role will ensure compliance with global standards including ISO 13485, ISO 14971, 21 CFR Part 820, and EU MDR.
You'll act as the Quality representative across cross-functional teams, applying expertise in risk management, design controls, and CAPA to drive product and process quality from concept to launch.
Key Requirements:

• Degree in Engineering or Life Sciences
• 5+ years' experience in Quality within medical devices
• Strong knowledge of ISO 13485, ISO 14971, FDA QSRs
• ASQ CQE preferred or willingness to obtain

This is a great opportunity for an experienced Quality Engineer to contribute to meaningful product innovation in a collaborative, growth-focused environment.
Apply now for more details.