Document Controller
London
Permanent
Competitive, depending on skills, experience and background
Working as part of a cohesive team in an established MedTech organisation, this role will see you provide administrative and document control support within the Quality function according to ISO 13485 and 21 CFR Part 820 requirements.
Core duties will include, but are not limited to:
* Collating, transmitting, filing and retrieval of documents which feed into the Quality team in line with company policy and procedures.
* Working with various teams to ensure documents are prepared and reviewed in a timely manner.
* Support Global QMS integration tasks.
* Provide Quality and Documentation training as required to other team members.
* Handling external document requests and archiving drawings and altered quality documents.
* Taking responsibility for the maintenance and calibration documents within the quality management system.
* Filing – both electronic and manual – of quality documents.
* Working collaboratively as part of a busy team and acting as the go-to person for all matters relating to document control.
Person specification:
* You will be highly precise with strong attention to detail; meticulous and a careful planner
* Minimum 3 A Levels or equivalent, BSc in a related field would be preferred (or equivalent)
* Prior experience of document control in a medical device/technology environment working to ISO 13485:2016 and CR 21 part 820 would be highly desirable
* Comfortable working within a highly regulated environment, with respect for protocol and commitment to quality processes
* Flexible in your ability to collaborate with a number of departments in a busy organisation
* Strong command of English communication both in writing and verbally
* Good working knowledge of MS Word, Excel, Outlook, and a variety of database
Sound like you?
Please apply now by attaching your CV in Word, or contact me for further information: bec.johnston@srgtalent.com