We've got a role for an Assistant Quality Manager. Our client is an exciting and innovating growing healthtech company.

They operate at the interface of biotech, pharma and digital technology industries, using the concept of convergence to create new models of care pathways, integrating feedback to optimise outcomes for patients and health systems.

The purpose of the role is to support stakeholders in the company and the Director of Quality in ensuring that the quality management system (EMS) is implemented, maintained and certified to ISO 13485.

Responsibilities and Duties

• Document control and system management:
  • Own the documents matrix and ensure documents are kept up to date and current.
  • Maintain document administration to ensure folders and restricted and documents are locked and are inspection ready.
  • Provide support on the use of the electronic QMS including access to new starters and revoking access for Leavers.
  • Support migration of documents and templates to the electronic QMS
  • Support validation activities of the eQMS.
• Other QMS related activities:
  • Generate quality KPIs for presenting at relevant meetings.
  • Oversee and support the CAPA process.
  • Carry out internal audits (on completion of training) and participate as required in joint audits.
  • Support supplier approval and evaluation process and work with stakeholders to ensure relevant documentation is maintained.
  • Support 13485 audit preparation and arrangement including arranging meetings and other provisions as required.

• Training activities:
  • Assign documents to staff to read and understand according to the training matrix. Send reminders as needed
  • Training matrix- ensure this is kept up to date and current.
• General tasks:
  • Organise quality meetings.
  • Supporting the Director of Quality in specific quality related projects.

Required Qualifications, Knowledge, Training and Experience

• Degree in a scientific discipline.
• Minimum three years of working within quality assurance in the life sciences sector is required.
• Experience of working in digital healthcare is highly desirable.

Key Personal Characteristics

• Effective interpersonal skills and strong communication talent in order to establish sound relationships with colleagues, key partners and clients.
• Methodical with the ability to follow procedures accurately.
• Excellent organisational skills with the ability to prioritise and adapt to dynamic priorities.
• Ability to work under pressure and meet deadlines whilst showing attention to detail.
• Flexibility, with an enthusiastic and confident approach; a willing member of the team.
• Dedicated to driving business growth, developing others and self.
• Keen learner who enjoys setting exemplary standards.
• Good with electronic systems, documents, ability to write documents, reports, make flow-charts from processes etc. as required.

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