About The Role
As our US Quality Lead, you will work within our multidisciplinary teams on major product development projects, be responsible for the development, evaluation and auditing of Design History Files (DHF) including remediation work for our clients and suppliers as well as internally. Your role will include supporting a selection of clients on a range of products and processes in primarily the medical sector. 

You will come from a Design and Development background and have a good understanding of New Product Development/Transfer to Manufacture. At this fantastic time to join the team, you will have numerous projects to get your teeth into and immediately add value. This role will suit an ambitious individual who is looking for career advancement and training and development opportunities. Positive, professional and confident you will have the ability to attend client meetings and lead projects in the future.
 
Our Raleigh facility is another step on the journey we are making to move closer to our international customers. Founded 25 years ago in Cambridge, UK, we have clients all over the world and, while healthcare innovation remains our largest sector, projects range from cookware to complex digital systems.

Specialising in healthcare, consumer, and digital innovation, our solutions start at the point a business decides upon the need for innovation and finishes with the launch of a breakthrough new product that is customer-focused and commercially effective.
 
 
 
About You
  • NPD & NPI/Transfer to Manufacture experience in the medical device or drug delivery development area
  • Experience of submissions to regulatory authorities including EU, US and ROW
  • Degree qualified
  • Experience of working within ISO 13485 quality management system
  • Ability to write technical documents in a methodical and timely manner 
  • Experienced at developing content for Risk Management Files including; Plans, Hazard Assessments, Design FMEA, Process FMEA and Risk Reporting
  • Ability to spot sales opportunities, write proposals and attend conferences with a view to building up a client database
  • Experienced at developing content for Design History and technical files
  • Excellent presentation and client management skills
  • Desire to lead projects and programmes, taking responsibility for quality, time and profit 
  • Experience in combination devices would be advantageous
  • A working understanding of electro-mechanical devices is desirable 
About Us
We are an employee owned company with our staff at the centre of our strategy. Employee ownership allows us to maintain full control over the direction of our business and our creative culture.

Work Authorization
Cambridge Design Partnership will only employ those who are legally authorized to work in the United States. This is not a position for which sponsorship will be provided. 

Equal Opportunity Employer 
Cambridge Design Partnership is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, marital status, political affiliation, sexual orientation, gender identity, genetic information, disability or protected veteran status. We are committed to providing a workplace free of any discrimination or harassment.

                                                 
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