Apply for Contract Quality Engineer Job On Vita CV
Contract Quality Engineer
Job Posted: 3 days ago
Salary: Competitive
Job Type: Contract
Location: Shire Oak
Expire in: 24 days
Job Description
Our client is a leading medical technology company that designs radiation delivery devices to support clinical teams and cancer researchers. For more than 25 years, they have been shaping the development of superficial and orthovoltage radiation therapy and advancing preclinical radiation research. They are seeking Contract Quality Engineer who will be responsible for the creation of new documents required by the quality management system, improve current processes and liaising with the various department to gather feedback on current processes.
Contract Quality Engineer
Initial 6-month contract
Monday – Friday (9am – 5pm)
Remote with occasional travel to site
Contract Quality Engineer
Job Description
Document Control Process:
Work with the QARA Manager and the Senior QARA Engineer to remediate all documents within the electronic document management system.
Catalogue external links within documents and establish a process for monitoring of external links.
Supplier Process:
Improve the supplier onboarding and supplier revaluation activities.
Create new documents to support the supplier process.
Establish controls for critical suppliers.
Create supplier quality agreements.
Translation Process:
Work with the QARA Manager and external translation house to identify gaps in the translation process.
Create new documents to support the translation process.
Update the translation process to meet the requirements of Regulation (EU) 2017/745.
Registration Process:
Create a documentation pack for each region to support registration of medical devices within Europe, Canada, Australia and the rest of the world.
Create a master list of active registrations where Xstrahl hold market authorisation.
Create a procedure/work instruction on the registration process.Contract Quality Engineer
Key Skills
Experience of working in a medical device industry as a quality/regulatory engineer.
Working knowledge of ISO 13485, ISO 14971 and Regulation (EU) 2017/745.
Experience working with an electronic document management system.
Experience in document control and use of an electronic document management systemBefore You Apply
Do not include the following in your job application, CV, or cover letter:
- Bank details.
- National Insurance number.
- Date of birth.
You should not be asked for payment or irrelevant information. If you have concerns about a job advert or employer, seek guidance on how to proceed.
© Vita CV: Registered in England and Wales (16187919).