TITLE: Design Assurance Engineer
DEPARTMENT: Quality
REPORTS TO: Quality Manager
LOCATION: Keele, UK
The role
Biocomposites continues to experience dramatic growth, realising our mission to increase the number of patients we can help, by extending our market coverage in new specialities and new geographies.
The Design Assurance Engineer will be responsible for coordinating and implementing design controls for medical device changes and new product developments, aid regulatory projects, research projects and technical projects. This will include maintaining and the Design Dossier (Design History File) and related Technical Documentation according to regulatory and QMS requirements.
What do we offer?
Competitive salary and benefits! With us, you will receive a competitive salary package and benefits.
We grow talent. At Biocomposites we create opportunities to thrive and grow.
One Biocomposites – team spirit & engagement. Our culture is important and we strive to create engaged and inclusive global teams that encourage colleagues to share their diverse perspectives and opinions.
Who do we look for?
People who are passionate about what we do.
People who are open minded to evolving the way we work.
People who can work together to transform outcomes and change lives.
REQUIRED EXPERIENCE:
• Bachelor’s Degree in a Mechanical, Engineering, life science or equivalent
• 3+ years design control or other design/research project management in a regulated environment
• Project management skills and an ability to work to tight timelines
• Enthusiastic and eager to learn, motivated to develop a career within design of Medical Devices
• Proficient in the use of Microsoft Office
• Excellent communication skills when liaising at all levels within the company and with external customers
• Medical Devices design training or ISO 13485 internal auditor qualification
• 5+ years design control or other design/research project management in a regulated environment
• Knowledge of electronic document management systems
• Specific knowledge of ISO 13485 design control requirements
• Working knowledge of medical device regulations globally
• Experience working in medical devices, pharma, automotive or aerospace manufacturing
• Working knowledge of ISO 13485
• Ability to present and chair meetings with senior board members
• Right to work in the UK
If you are interested please forward your CV and cover letter stating the position you wish to apply for to careers@biocomposites.com