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- Posted on 28th March 2019

QA Manager

Oxford, UK

Location: Oxford, UK

Contract:  Full time

Seniority Level: Mid-senior level

Closing date: 5th Apr 2019

We are seeking a Medical Device Software QA Manager to join our growing RA/QA department.  The QA/RA department supports the company at a corporate level and regionally in both the UK and the US. With the support of the Executive Management Team and Board of Directors, the QA/RA department supports the company to meet quality standards and objectives in all areas of the business.

The QA Manager reports to the Head of Regulatory Affairs and has responsibility for the maintenance and continuous improvement of the QMS in accordance with quality standards and guidelines, QA planning and budgeting.

 

RESPONSIBILITIES

  • Oversee all company and project QA activities
  • Plans and estimates for all QA work of self and others
  • Responsible for the maintenance and continual improvement of the Quality Management System
  • Manage the development and delivery of process improvements and measurement of process performance
  • Manage implementation of new or updated quality regulations, standards and guidance
  • Managing Quality Management System changes as a result of regulatory requirement changes
  • Coordination of staff process and quality system training
  • Lead internal, external and supplier audit activities and process
  • Manage corrective and preventive action process
  • Quality oversight of complaint handling
  • Planning and coordination of quality activities for design and development projects
  • Review of documentation for design and development projects
  • Management of certification and accreditation activities with external bodies
  • Responsible for all liaisons with external certification and accreditation bodies on behalf of the company
  • Monitoring for Quality Management System changes which may affect products and company registration
  • Quality review of business to business contracts.
  • Planning and coordination of regulatory activities for products and development projects, in conjunction with Product Management.
  • Reviewing Risk Management activities for development projects
  • Involvement in regulatory certification and accreditation activities with external bodies
  • Liaising with external consultants and agents, as required.
  • Monitoring regulatory bodies for changes which may affect products and company registration
  • Involvement in global vigilance activities and system and oversight of post-market surveillance processes
  • Lead Quality Management Review
  • Supervisory responsibilities for all departmental controls and procedures
  • Maintaining a fair and consistent approach

SKILLS AND EXPERIENCE 

Essential Skills
  • 5 years + commercial QA experience in a medical device environment
  • Experience of managing external audits from notified bodies
  • Performing internal and supplier audits
  • Experience of establishing company quality objectives
  • CAPA management
  • Lead Auditor (ISO 9001 or ISO 13485)
  • Detailed knowledge of quality standards including:
    • ISO 13485:2016, ISO 14971, IEC 62304, IEC 62366
  • Experience of taking a key role within a quality regulated environment, developing quality processes and driving process improvement
  • Experience of establishing company quality objectives
  • Ability to manage change
  • Ability to train others in Quality related procedures
  • Process design and implementation
  • Ability to liaise with suppliers, resellers, agents and consultants
  • Excellent written and verbal communication skills at all levels
Advantageous Skills
  • Knowledge of
    • MDSAP, EU MDR, US CFR 21 Part 820 (CGMP)
  • Knowledge/experience of software development lifecycles
  • Line management experience
  • Application of Risk Management techniques
  • Understanding of product regulatory clearance requirements for Europe, North America, APAC including labelling and post-market surveillance requirements and complaint handling.