£50000 per annum
about 1 month ago
Our client is looking to recruit a new team member to join their busy and thriving business.
Duties are as below:
· To provide comprehensive assistance to the Directors to ensure the efficient management and continued improvement of the Company Quality Management System (QMS).
· To ensure continued certification to the current version of ISO 13485 and any further standards identified as relevant to the company’s activities.
· To provide QARA strategic planning and framework for achievement of Company commercial and quality goals.
· To ensure that all products are compliant to current legislation and regulations.
· To promote Quality, QMS and best practice awareness at all levels of the business.
· To develop and train direct reports and other relevant staff to minimise reliance on key personnel.
· To ensure that changes to the Medical Device Directive/Regulation and Quality standards are disseminated throughout the Company and appropriate risk analysis and actions are managed.
· To protect the assets of the Company, manage risk and other quality related activities.
· To ensure records are maintained in accordance with Company policies and procedures meeting current legislation, including GDPR requirements.
· To promote the Company’s purpose and vision and ownership of its values and strategic objectives.
· To provide data and analysis assistance to the Directors to ensure the efficient management and continued improvement of the Company Quality Management System (QMS).
· To ensure continued certification to the current version of ISO 13485 and any further standards identified as relevant to the Company’s activities.
· To ensure processes are implemented and undertaken to ensure that Notified Body non-conformities are minimised.
· To provide QARA strategic planning and framework for achievement of company commercial and quality goals.
· Work closely with other key departments within the business to support and advise on good working practices in line with the requirements of applicable Medical Device legislation.
· Plan and allocate resources to ensure internal quality workload is planned efficiently.
· To identify improvements and cost-effective processes to meet customer and quality standards and minimise waste.
· To assist with the Company’s future strategy and direction of developing a first-class manufacturing capability and helping to build on its continuous process improvement programme.
· Have a very good understanding of current MDR and related quality standards and be aware of forthcoming changes which may impact upon the business.
· Be responsible for self-development and to participate in the Company’s performance development process.
· To comply with all Company policies and procedures.
Expected Abilities/Skills Required of the Jobholder:
· At least 5 years in a senior Quality Assurance management role.
· Educated to degree level, or equivalent.
· Qualified Auditor or Lead Auditor preferred.
· An excellent working knowledge of ISO13485 and other, relevant, standards.
· Experience of working in the medical device, or equivalent, industry.
· Knowledge and practical experience with analytical/statistical techniques.
· Be assertive and able to take charge of a situation where appropriate with the ability to motivate and influence others.
· Positive attitude to continued professional development for self and team.
· Able to manage multiple projects continuously.
· Good computer skills (proficient in Microsoft Word & Excel).
· Excellent eye for detail and accuracy.
· Autonomous and decisive.
· Able to communicate effectively at all levels.
· Accurately recording and communicating information.
· Ability to work to deadlines and to prioritise with a methodical approach.
· Ability to work under pressure whilst remaining focused and professional.
· Reliability, motivation and willingness to learn, grow and develop.
· Well organised and focused on work quality.
· Positive, self-starter attitude and desire to exceed expectations at every opportunity.
· Sets high standards of performance for self.
If you are interested in this role please send your CV to email@example.com