Quality Assistant

Job content

Come and join our team at Osteotec. We are searching for an outstanding candidate for our Quality Assistant vacancy.

If you have a passion for the medical device industry, a life sciences degree, and some experience in a quality or regulatory function or a related discipline we’d love to hear from you.

Job Title: Quality Assistant

Brief Role Description: The Quality Assistant will support the Quality and Regulatory Officer in maintaining an accurate and effective Quality Management System in accordance with medical standards.

Hours per Week: Full Time

Location: Head Office

Responsibilities:

· Supporting the Quality Manger with QMS document completion and online record storage in accordance with ISO13485 and ISO 9001

· Assisting with the Non-conformance process and ensuring target deadlines are met

· Performing the approval process for new and amended Standard Operating Procedures, ensuring new and superseded documentation is correctly filed

· Liaising with potential suppliers, customers and distributors, obtaining relevant approval information and auditing where necessary to ensure Osteotec’s Quality standards are met

· Supporting managers with Training records

· Monitoring manufacturing process and ensuring safety of the devices

· Assisting with Osteotec devices technical files and ensuring records are updated accordingly

· Data collection from QMS and analysis, to aid continuous improvement

· Collaborate with UK sales team and overseas partners to gain post-market feedback

· Assisting with Internal Audit organisation and reporting

· Administration tasks in relation to UK Responsible Person service.

· Any other relevant, reasonable ad hoc duties that may be requested.

Essential:

· A high level of attention to detail and ability to follow procedures accurately

· Excellent written and verbal communication skills

· Highly organised and able to work alone when required

· Proficient with Microsoft Office (Excel, Word, PowerPoint, Outlook)

· Maths and English Language A level, preferably grade B or above Desirable

· Previous experience in quality management

· An ambition to develop a career in a QARA function in the medical device industry

Highly Desirable:

· A Degree in any relevant scientific discipline

· Experience in regulatory affairs or in quality management systems relating to medical devices.

Competencies:

· Decision Making/Judgement – Selects effective approaches to solving issues, based on available information and business objectives and escalates appropriately.

· Relationship Builder – Builds and maintains relationships within the team and across the wider organisation.

· Excellent communication skills.

· Proactive - Has a pro-active and independent personality, ability to manage their own workload and prioritise appropriately.

· Strong internal drive and motivation to make a difference and add value to an organisation.

This Job description is not exhaustive but outlines the main requirements.