Quality Assurance Associate
We are seeking a person with a passion for quality management and a desire to help create great new products and services, and get them to market. The primary objective of this role is to work with the Quality and Capabilities Manager to maintain IDE’s ISO 13485 certified, ISO 9001 and 21CFR820 compliant quality management system. Therefore as the Quality Assurance Associate, you will have a strong knowledge of these standards and regulations.
You will be responsible for maintaining quality management system and achieving compliance and championing quality throughout the organisation. You will often be working in uncertain and uncharted environments, and need to be comfortable doing so as part of a team responsible for developing and delivering complex products that realise new futures for our clients worldwide.
We need someone with an ability to communicate effectively and work with our Design Leadership & Entrepreneurship, Product Development, Manufacturing and Finance Groups, as well as external stakeholders such as Clients and Customers and suppliers (domestic and overseas) in order to achieve Quality, Delivery and Cost targets. You must also be able to organise and run improvement projects, manage budgets and timelines.
You will be responsible for managing a timely and efficient CAPA process, undertaking internal audits and supplier audits, training employees in IDE’s processes and quality management principles and managing the control of documentation and records. You will report to Quality and Capabilities manager on the performance of the quality management system and any need for improvement.
Critical to this role will be experience within highly regulated, safety critical industries and experience in complying with various standards and strict regulations will be regarded highly. The role will be hands on yet you will need to understand how your work affects the bigger picture across IDE.
Desired Skills and Experience
A minimum of three years’ experience working in a quality role. Preferably in the medical device industry. Key specific areas of desired qualifications, knowledge and experience required for this role include:
A degree in Mechanical, Mechatronics or Biomedical Engineering, Industrial Design or similar applicable technical discipline.
Very fine attention to detail, and a passion for efficiency and technical quality in design, development and manufacturing documents.
A demonstrated understanding of ISO 13485 or ISO 9001.
Experience in implementing Good Manufacturing Practice principles and a good understanding of 21CFR820.
Experience in undertaking internal and supplier audits.
A demonstrated ability to effectively train people on quality management principles and on how to comply with quality management systems.
Experience in undertaken risk management and risk analysis activities, including Hazards Analysis and FMEA.
Experience collaborating on design problems within a multi‐disciplinary R&D environment.
Ability to communicate an engineering approach from requirements through to execution.
Experience in undertaking manufacturing planning, quality control and process validation in medical device manufacturing environments.
If you are ready and have the right skills, experience but most importantly, attitude, then a role in a truly unique, award winning group passionate using design and entrepreneurship to create new businesses awaits. Please email your resume and cover letter at email@example.com