Quality Assurance & Regulatory Affairs (QARA) Manager

  • Location

    Hereford

  • Sector:

    Professional & Technical

  • Job type:

    Permanent

  • Salary:

    £50000 per annum

  • Contact:

    Zena Williams

  • Contact email:

    zwilliams@meridianbs.co.uk

  • Contact phone:

    01432 261444

  • Job ref:

    ZW-3

  • Published:

    about 1 month ago

  • Expiry date:

    2021-02-24

  • Startdate:

    2021-01-25

  • Consultant:

    ConsultantDrop

Are you a experienced and diligent Quality Assurance and Regulatory Affairs Manager looking for a change?
Our client is looking to recruit a new team member to join their busy and thriving business.
Duties are as below:
Overall Purpose
·      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.
Principal Accountabilities:
·      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.
 
 
General:
·      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 zwilliams@meridianbs.co.uk