Job summary
Are you a dynamic, talented Quality Assurance Oriented professional looking for an opportunity to extend and enhance your experience and knowledge?
Voted 'Best place to work in IT' at UK IT Industry Awards 2022, we have an opportunity for the position of Quality Manager (Regulatory Compliance). You will be joining a small but highly skilled Quality & Regulatory team within Digital Health Care Wales (DHCW).
DHCW design, procure, build and operate a wide range of Health and social care services for NHS Wales; the Quality & Regulatory Compliance team provide assurance through the full product life cycle.The team members are the subject matter experts on Quality Management, Audit, Validation and Medical Device Regulations, supporting DHCW and other NHS organisation. A primary focus for this role will be continuing the development of end to end product life cycle processes to ensure DHCW are in a position to meet the requirements of the UK Medical Device Regulations.
Main duties of the job
- The provision of effective and highly visible leadership of the Quality Management, Validation and regulatory compliance team supporting the strategic development of Quality and Regulatory Compliance throughout the Organisation
- Managing and ensuring that DHCW meets all the legal, regulatory, and professional requirements of Computer Systems Validation, Medical Devices Regulations and The Medical Devices (Amendment etc.) (EU Exit) Regulation. This includes supporting the overall responsibility for the release of Software against the regulations including categorisation of the Medical Device, Product release and submission to the regulatory authorities.
- Ensure that processes for the Quality Management System (QMS) are established, maintained, and fit for purpose and that data is made available to support business processes. This will include that systems are in place to ensure the safety & quality of systems meet the appropriate legislation & regulatory requirements
- Develop and maintain the internal audit schedule in line with the standard requirements. This will include building an internal auditor training program and working with the standard leads to ensure compliance with this
About us
Digital Health and Care Wales (DHCW) is part of the NHS Wales family and has an important role in changing the way health and care services are delivered through technology and data. The organisation supports frontline staff with modern systems and access to important information about their patients, while empowering the people of Wales to manage their own health through digital NHS Wales services.
Working for DHCW offers lots of employee benefits, including flexible working, a competitive salary, 28 days of annual leave plus Bank Holidays and opportunities for career development. We are committed to recognising and celebrating our staff as the most valuable part of our organisation.
Join our game changing, life-saving team and start making a real difference to health and care services in Wales.
Job description
Job responsibilities
The role of the Quality Manager (Regulatory Compliance) is accountable to the Head of Quality & Regulatory Compliance. The purpose of this role is to support the Quality and Regulatory Department in its strategic development, delivery, management, and continual improvement of the Quality Management System throughout DHCW with a direct focus on compliance and Validation.
This role will support the development and delivery of the DHCW vision, IMTP and Quality objectives, whilst ensuring compliance to applicable regulations and supporting standard leads.
In summary the role will lead the organisation in:
- Developing process in line with MHRA guidance to enable the organisation to meet the requirements of Medical Device Regulations
- Ensuring compliance to all applicable regulations and legislation
- Take responsibility and oversight of the internal audit schedule to ensure that standard requirements are met throughout the organisation
- Assist is supporting and preparation for external audits from the notified Bodies
- Become the lead in application of the QMS
- Ensuring Quality Risk Management is embedded throughout organisation
- Support training and application of standard requirements throughout the organisation
Ensuring routine Quality Monitoring is undertaken and that Quality Improvement programmes are implemented where necessary and develop metrics and key performance indicators
Job description
Job responsibilities
The role of the Quality Manager (Regulatory Compliance) is accountable to the Head of Quality & Regulatory Compliance. The purpose of this role is to support the Quality and Regulatory Department in its strategic development, delivery, management, and continual improvement of the Quality Management System throughout DHCW with a direct focus on compliance and Validation.
This role will support the development and delivery of the DHCW vision, IMTP and Quality objectives, whilst ensuring compliance to applicable regulations and supporting standard leads.
In summary the role will lead the organisation in:
- Developing process in line with MHRA guidance to enable the organisation to meet the requirements of Medical Device Regulations
- Ensuring compliance to all applicable regulations and legislation
- Take responsibility and oversight of the internal audit schedule to ensure that standard requirements are met throughout the organisation
- Assist is supporting and preparation for external audits from the notified Bodies
- Become the lead in application of the QMS
- Ensuring Quality Risk Management is embedded throughout organisation
- Support training and application of standard requirements throughout the organisation
Ensuring routine Quality Monitoring is undertaken and that Quality Improvement programmes are implemented where necessary and develop metrics and key performance indicators
Person Specification
Qualifications and/or Knowledge
Essential
- Educated to masters Level in a Quality Assurance Qualification or demonstrable equivalent experience.
- GAMP Certification
- Prince 2 / Project Management or demonstrative equivalent experience
Desirable
- Relevant approved Quality, Regulatory compliance qualification
- Lead auditor qualification
- Registered with a relevant informatics professional body
- Expert knowledge of the requirements of MHRA, HTA, CPA and ISO standards
Experience
Essential
- Extensive previous experience at management level
- Extensive experience of process management and procedural knowledge
- Extensive experience of quality systems and processes/policies in a regulated environment in specific validation and compliance areas
- Experience of using research to understand and implement best practice.
- Significant experience at Troubleshooting
- Significant Problem-solving experience
- Proven track record of managing a group of staff, and having responsibility for quality functions across a wider operational area where there is not line management responsibility
Desirable
- Demonstrable experience in developing policies with MHRA, government and other regulated environments
- Experience of developing policies to underpin quality management
- Experience of working with electronic quality management systems
Aptitude and Abilities
Essential
- Computer literate and working knowledge of Microsoft Office and incident and electronic quality management systems
- Strategic development skills
- Ability to communicate effectively both orally and in written format
- Ability to work effectively as part of a Team
- Ability to perform audits
- Ability to perform Risk Assessments
- Policy development skills
- Excellent organisational and interpersonal skills
- Highly developed communication skills
- Strong ability to analyse problems and suggest improvements
- Presentation skills
- Decision making skills
- Training skills
- Successful management of change
- Managing and developing IT systems to support quality assurance and control
Desirable
- Ability to Speak Welsh to Level 1
Person Specification
Qualifications and/or Knowledge
Essential
- Educated to masters Level in a Quality Assurance Qualification or demonstrable equivalent experience.
- GAMP Certification
- Prince 2 / Project Management or demonstrative equivalent experience
Desirable
- Relevant approved Quality, Regulatory compliance qualification
- Lead auditor qualification
- Registered with a relevant informatics professional body
- Expert knowledge of the requirements of MHRA, HTA, CPA and ISO standards
Experience
Essential
- Extensive previous experience at management level
- Extensive experience of process management and procedural knowledge
- Extensive experience of quality systems and processes/policies in a regulated environment in specific validation and compliance areas
- Experience of using research to understand and implement best practice.
- Significant experience at Troubleshooting
- Significant Problem-solving experience
- Proven track record of managing a group of staff, and having responsibility for quality functions across a wider operational area where there is not line management responsibility
Desirable
- Demonstrable experience in developing policies with MHRA, government and other regulated environments
- Experience of developing policies to underpin quality management
- Experience of working with electronic quality management systems
Aptitude and Abilities
Essential
- Computer literate and working knowledge of Microsoft Office and incident and electronic quality management systems
- Strategic development skills
- Ability to communicate effectively both orally and in written format
- Ability to work effectively as part of a Team
- Ability to perform audits
- Ability to perform Risk Assessments
- Policy development skills
- Excellent organisational and interpersonal skills
- Highly developed communication skills
- Strong ability to analyse problems and suggest improvements
- Presentation skills
- Decision making skills
- Training skills
- Successful management of change
- Managing and developing IT systems to support quality assurance and control
Desirable
- Ability to Speak Welsh to Level 1
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
