Ensera Design is a world-class user-centred innovation and product development consultancy, specializing in the medical and consumer health sectors with offices in Bristol, Colorado and New Jersey. As part of Ensera, we collaborate globally with contract manufacturing facilities in Europe, the USA, and Asia.
We are currently seeking an experienced Senior Design Quality Engineer to join our talented team and contribute to delivering exceptional solutions for our clients.
The role will be responsible for the day-to-day management, oversight, and continuous improvement of Quality activities. This role ensures all quality related activities are executed in compliance with applicable EU MDR, EMA, and FDA regulations, including 21 CFR Parts 820, 210, 211, internal procedures, customer requirements and all other industry applicable regulations and standards.
You will partner with electromechanical and software engineering and design teams to deliver new products to market in compliance with required quality requirements and processes.
You will guide project teams through consistent, compliant and lean delivery according to Design Control and Risk Management processes.
You will provide clear updates to stakeholders across the business and provide guidance on project readiness.
You will develop, maintain complete and compliant Design History Files and support the development of regulatory submissions for new products including pre-submission, 510(k) and other product required regulatory submissions.
You will interface with external regulatory experts and clients to drive collaborative delivery of Design History Files.
You will Support the continual improvement of Quality System processes and tools that support the product development process.
You will provide coaching and training to other teams relating to Design Control processes and continuous improvement.
You will support our quality and delivery teams with carrying out QMS and project audits when required including participation as a subject matter expert when required.