About the role
We are looking for an experienced Quality Engineer to work with our mechanical, electronic design engineering and quality management teams. Due to the varied nature of our consultancy work, the role is a varied and flexible one, encompassing a range of responsibilities including:
• Translation of regulatory requirements into product requirements
• Ensuring compliance with relevant standards and regulations
• Responsibility for risk management activities in line with ISO 14971 and design verification
• Development of key regulatory documents such as design inputs, and design reviews
• Review of requirements for traceability
• Planning verification programmes including establishing acceptance criteria and sample sizes
• Understanding clients’ QMS processes and ensure our team are working to them, where necessary
• Performing analysis and interpretation of test data, including statistical analysis, where necessary
• Supporting client audits
• Supporting the creation and reviewing of Technical Files / DHFs
• Reviewing clients’ documentation in line with in house SOPs and regulatory requirements
• Review of small batch production work instructions and processes to ensure quality assurance
• Interpreting and responding to feedback from the FDA with regards to device submissions
• Responsibility for regulatory intelligence monitoring
• Knowledge and application of implementation of key standards
• 10 Years’ experience in Medical Device Development
• Knowledge of medical device regulation in key market (US and EU)
• Degree in engineering or related technical discipline
• Experience of risk management with regard to medical product development
• Understanding of medical device directive 93/42/EEC, ISO13485 and FDA QSR
• Experience of design verification
• Knowledge and experience of implementing IEC 60601 and IEC62304
Get in touch
We’d love to hear from you if you think you would be a great fit (unless you’re a recruitment consultant). We embrace equality and diversity in our business, it’s really important to us.
Deadline for submissions is Monday 5th August 2019. Salary will be commensurate with experience.
Please send CV and a covering letter to [email protected] with KDQE and your name in the subject line of the email.
Only successful applicants will be contacted.
Kinneir Dufort (KD) is a world class User-Centred Innovation and Product Development Consultancy, with a 42-year track record of creating life changing world class products and experiences for global clients in medical, consumer and industrial sectors.
We are driven to collectively Design a Better World, achieving positive outcomes for the people we are designing for and generating value for our clients. We describe ourselves as a group of people focused on being open, smart, curious, pioneering, demonstrating respect and ensuring we have fun along the way.
Why work with us?
We understand that we are only as good as the people in our team and how important it is to support them. We offer 25 days holiday a year (with extra days for long service), a matched contributory pension scheme, private health care for you and your family, an employee assistance scheme, company-wide bonus, training and development opportunities and everything else from mindfulness to yoga to daily fresh fruit. Alongside this are monthly socials, parties, flexible start and finish times and the opportunity to work alongside some of the smartest and most inspiring people you will ever meet. We’re ambitious and driven to be best in the world at what we do.