Quality Assurance Assistant

A Quality Assurance Assistant to support the Quality Manager to ensure compliance with ISO13485:2016 medical device quality standards and other applicable regulatory standards. The Company is expanding and needs someone to support the Quality Manager on a range of client and inhouse projects. The successful candidate will be provided with training and ample opportunity to take on additional responsibility and advance their career.

• Assist the Quality Manager with the maintenance of the ISO 13485 Quality Management System (QMS).
• Create, revise and control documents including standard operating procedures, supplier approvals, forms, and templates. This will involve close collaboration with people in manufacturing, R&D, and logistics.
• Initiate, follow up and close deviations, change control and CAPA (corrective action preventative action).
• Keep accurate records and filing of documents.
• Review manufacturing batch documents, coordinating with the Quality Manager for batch release of medical device components.
• Keep the internal training database up to date with all relevant documents and coordinate quality training activities.
• Work with the production team to provide operational QA oversight of manufacture in ISO Class 7 Cleanrooms.
• Promote continuous improvement within the organisation.
• Perform such other tasks that may be required from time to time.

• Experience of working in a quality-controlled environment e.g., ISO13485 / 9001 /GLP/GMP.
• A hard-working can-do attitude, enthusiasm, and eagerness to learn and drive continuous improvements.
• Self-motivated, resilient, and able to organise own workload and manage competing priorities
• Strong report writing skills, with the ability to document risks and controls clearly and concisely.
• A strong attention to detail.
• Excellent written and verbal communication skills with the ability to build and maintain good professional relationships internally and externally.
• Competent with MS Office software (MS Word, PowerPoint, Excel etc) and project management software.

• Teamwork: taking individual responsibility and supporting team members.
• Transparency: communicating openly and highlighting issues promptly.
• Excellence: delivering high quality outputs; aware of priorities and deadlines.
• eager to drive continuous improvements.
• Consideration: considerate with concern for impact on others.
• Learning: embracing personal development and enthusiastic to learn.

Please note: Only candidates with the relevant skills and experience will be contacted regarding this position. If you do not hear back from us within 5 days you have unfortunately been unsuccessful in your application for this position, however we may contact you in the future to discuss other opportunities.

Please note that no terminology in this advert is intended to discriminate on the grounds of a person's gender, marital status, race, religion, colour, age, disability or sexual orientation. Every candidate will be assessed only in accordance with their merits, qualifications and abilities to perform the duties of the job.