Design Assurance Engineer

Description

Quanta Dialysis Technologies, a leader in the medical devices industry, is currently seeking a skilled Design Assurance Engineer to join our team. As our company's purpose is to create beautifully engineered devices and services that improve dialysis experiences and everyday living, our Design Assurance Engineer will play a crucial role in ensuring the quality and safety of our products. Working closely with our R&D and engineering teams, the Design Assurance Engineer will help to ensure that our technologies are simple, easy to use, accessible, and empowering - setting people free and giving them the chance to feel like a person, rather than a patient.

Responsibilities

• Develop, implement, and maintain design control processes
• Create and execute product verification and validation plans
• Perform risk assessments and manage risk mitigation activities
• Provide guidance and support for regulatory compliance
• Conduct internal audits and support external audits
• Collaborate with R&D and Engineering teams to ensure robust design for manufacturability
• Continuously evaluate and improve product quality

Requirements

As the preferred candidate for the role of Design Assurance Engineer you'll have:

• Manufacturing/Design/Quality engineering qualifications with experience within a medical device design and manufacturing environment.
• Preferably experienced with Class 11 & 111 medical devices, ideally complex programmable electromechanical devices incorporating software, pneumatics, fluidics, and electronic control systems.
• Proven experience with design controls, verification and validation, risk management, and regulatory compliance

Benefits

In return we offer:

• Competitive base salaries dependant on experience
• Company bonus scheme
• Life Assurance
• Income Protection
• Flexible working conditions
• Perkbox

This is a chance to truly make a difference, not only to patients but to an entire industry where the treatment and therapy concept has not evolved for years. If you meet the criteria for Design Assurance Engineer send your CV now and we'll be in touch for a confidential chat. Your next career move could be just round the corner!