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 diverse 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, application and implementation of key standards
• 10 Years’ experience in medical device development
• Knowledge of medical device regulation in key markets (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
At Kinneir Dufort (KD) we combine creative, technical and user experience expertise, working collaboratively, and with agility, to rapidly define, create, develop and deliver world-changing products and experiences.
We think KD is a special place. Our team are intelligent, hard-working, fun, non-egocentric, and collaborate brilliantly together to produce creative solutions, working with some of the biggest, best and most interesting international clients you’ll find anywhere. We’re a multi-disciplinary team of 75, with experts in research, innovation, human factors, digital UX, 2D and 3D product & packaging design, engineering, prototyping, and electronics & software, all uniquely integrated within one building.
Our team are collectively driven to “design a better world” by creating impactful change and positive outcomes for our clients and the people we are designing for. Designing a better world is something we strive for, both in the work we do, and the way we work. We believe strongly in equality and fairness, and try hard to do the right thing; we speak up and support groups who are working to make a difference. Our official KD partners are the RSA, Frank Water, Kerning The Gap, TeenTech, Babbasa, and The Big Bang. Many of our team are also involved in, or run events in their local communities, making a difference to those around them.
Founded in 1977 by Ross Kinneir and Francis Dufort, the KD team are based in an iconic building in the vibrant city of Bristol. The characterful Grade 2 listed stone building, was originally built as a sugar refinery around 1850, and was later used to store theatre costumes. It’s now completely refitted, and houses all our staff plus our workshops, labs, the design studio, HF usability suite, and client meeting spaces. The local area, “Christmas Steps Arts Quarter”, is full of independent shops and makers. It’s a short walk up to Park Street, or over to the Harbourside and St Nick’s Markets, both of which have regular street food markets, and a few minutes further to the Georgian splendour of Queen Square.
Today, our business and teams are expanding rapidly as we acquire new clients and projects, and as a result we are building new adjacent offices. Work on the new glass building is due to start in early 2020, and when complete we’ll connect the two buildings together. Having all of our staff, skills and equipment in one location ensures we quickly exchange ideas, and can continuously work as multi-disciplinary teams.
Check out our Instagram account to gain an insight into what life is like as part of the KD team, and inside KD HQ.
Why work with us
We are only as good as the people in our team, and we know how important it is to support them so that they can do and be their best. As part of the KD team, you’ll be working 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.
We offer our staff,
- 25 days holiday a year (with extra days for long service)
- A matched contributory pension scheme
- Company-wide bonus
- Private health care for you and your family; free eye tests plus an employee assistance scheme for you
- Training and development opportunities, and regular lunch and learn sessions
- Flexible start and finish times: most staff take advantage of our new scheme! We all work core hours 09:30 – 16:00, and then benefit from an early finish of 12:00 on Fridays.
- Secure in-building bike storage and shower, discounted First Bus monthly and annual passes. (Bristol has a good Park & Ride bus network.)
- The opportunity to become involved in our work with the RSA, Frank Water, Kerning The Gap, TeenTech, Babbasa, The Big Bang.
- Our cafe acts as the focal point for the whole agency to get together for morning coffee, lunch and afternoon tea. There is always daily fresh fruit and usually cake! Staff also organise KD runs and yoga sessions, plus monthly “Firsty Friday” socials.
How to apply
Salary will be commensurate with experience.
Please email your CV and covering letter to [email protected]
Only successful applicants will be contacted.
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 Tuesday 17th December 2019