Snr Design Quality Engineer

ZipRecruiter; Ashford; Hybrid; GBP 60,000; Full time

Job summary

A leading medical device company seeks a Senior Quality Engineer to enhance product development and maintain compliance with global standards. This hybrid role offers a salary circa £60,000 and requires expertise in risk management, design controls, and CAPA, contributing to product innovation in a collaborative environment. Candidates should hold a degree in Engineering or Life Sciences and have over 5 years of relevant experience.

Qualifications

• 5+ years' experience in Quality within medical devices.
• ASQ CQE or willingness to obtain.

Responsibilities

• Support product development and change control activities.
• Ensure compliance with global standards including ISO 13485, ISO 14971, 21 CFR Part 820, and EU MDR.
• Act as the Quality representative across cross-functional teams.

Skills

ISO 13485

ISO 14971

FDA QSRs

Risk Management

Design Controls

CAPA

Education

Degree in Engineering or Life Sciences

Job description

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 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.