Quality Officer

Job summary

UKHSA operates as a legal manufacturer and distributor of medical devices (MDs), including in vitro diagnostic devices (IVDs), Software as a Medical Device (SaMD), and associated accessories. These devices fall into two categories:

• Commercial MDs/IVDs – intended for market distribution and subject to full regulatory compliance.
• In-House IVDs – used exclusively within the organisation under the Health Institution Exemption.

To support these functions, UKHSA maintains a robust Quality Management System (QMS) aligned with ISO 9001 and ISO 13485 standards. The Quality Officer will report to the Senior Quality Specialist and contribute to the effective management and continuous improvement of the QMS, ensuring compliance with relevant regulatory frameworks, by working with both internal, and external stakeholders.

Working for your organisation

We pride ourselves as being an employer of choice, where Everyone Matters promoting equality of opportunity to actively encourage applications from everyone, including groups currently underrepresented in our workforce.

UKHSA ethos is to be an inclusive organisation for all our staff and stakeholders. To create, nurture and sustain an inclusive culture, where differences drive innovative solutions to meet the needs of our workforce and wider communities. We do this through celebrating and protecting differences by removing barriers and promoting equity and equality of opportunity for all.

Please visit our careers site for more information https://gov.uk/ukhsa/careers

Job description

• Administer and maintain controlled documents (e.g., SOPs, forms, work instructions, manuals, risk assessments) within the Q-Pulse QMS.
• Upload and manage audits, non-conformances, quality improvements, and change controls in Q-Pulse.
• Coordinate cross-functional teams within Quality, Regulatory & Assurance to address quality issues.
• Ensure work is delivered to specification, appropriate schedule, and high standards of quality.
• Support and implement local Quality Management Systems.
• Maintain a program of continuous improvement

This list of duties is not exhaustive.

The Quality Officer will be a key member of the Regulatory Assurance and Compliance Unit, which oversees regulatory compliance across the Public Health Microbiology Directorate, part of the wider Science Group within UKHSA.

This role involves supporting the development, implementation, and maintenance of the organisation’s Quality Management System, ensuring it remains compliant with ISO 9001 and ISO 13485 standards, and other applicable regulations for medical IVD and other devices.

• Conduct internal and external ISO-based audits per schedule or senior management request.
• Consult with operational teams to define procedures and processes for internal audits.
• Write audit reports and agree corrective actions with relevant teams.
• Monitor and report progress of corrective actions.
• Assist operational teams in defining and delivering continuous improvement programs.
• Supervise delivery of defined QMS elements (e.g., data or protocol review) as directed.
• Train operational teams on QMS elements as agreed with the Senior Quality Specialist.
• Undertake special projects as assigned.
• Deputise for the Senior Quality Specialist when required.

The above is only an outline of the tasks, responsibilities and outcomes required of the role. You will carry out any other duties as may reasonably be required by your line manager. This list of duties is not exhaustive.

Person specification

Essential Criteria

• BSc in Life Sciences or equivalent, or demonstrable experience in a Quality Assurance role.
• Experience or knowledge with electronic QMS platforms (e.g., Q-Pulse).
• Proficiency in Microsoft Office and digital systems.
• Strong verbal and written communication, data analysis, and statistical skills.
• Ability to work independently and collaboratively.
• Excellent interpersonal, negotiation, and organisational skills.
• Initiative-taking, analytical, and adaptable.
• Commitment to learning UK medical device regulations.
• Ability to follow relevant policies, procedures, and legislation.
• Confident decision-making, with initiative and appropriate escalation

Desirable Criteria

• Regulatory compliance knowledge.
• Practical auditing experience.
• Experience in a quality/regulatory setting.
• Familiarity with ISO standards such as ISO 13485:2016 and ISO 15189:2022

Benefits

Alongside your salary of £33,422, UK Health Security Agency contributes £9,682 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides.

• Learning and development tailored to your role
• An environment with flexible working options
• A culture encouraging inclusion and diversity
• A Civil Service pension with an employer contribution of 28.97%

Things you need to know

Artificial intelligence

Artificial intelligence can be a useful tool to support your application, however, all examples and statements provided must be truthful, factually accurate and taken directly from your own experience. Where plagiarism has been identified (presenting the ideas and experiences of others, or generated by artificial intelligence, as your own) applications may be withdrawn and internal candidates may be subject to disciplinary action. Please see our candidate guidance (opens in a new window) for more information on appropriate and inappropriate use.

Selection process details

This vacancy is using Success Profiles and will assess your Behaviours and Experience

Stage 1: Application & Sift

Success Profiles

You will be required to complete an application form. You will be assessed on the listed 10 essential criteria, and this will be in the form of a:

• Application form (‘Employer/ Activity history’ section on the application)
• 1000 word Supporting Statement.

This should outline how your skills, experience, and knowledge, provide evidence of your suitability for the role, with reference to the essential criteria.

The Application form and supporting statement will be marked together.

Please note you will not be able to upload your CV. You must complete the application form in as much detail as possible. Please do not email us your CV.

Longlisting

In the event of a large number of applications we will longlist into 3 piles :

1. Meets all essential criteria
2. Meets some essential criteria
3. Meets no essential criteria

Those falling into the ‘Meets all essential criteria’ and meets some essential criteria pile will progress to interview stage

Feedback will not be provided at this stage.

Shortlisting

In the event of a large number of applications we will shortlist on the following essential criteria:

• BSc in Life Sciences or equivalent, or demonstrable experience in a Quality Assurance role

Desirable criteria may be used in the event of a large number of applications/large amount of successful candidates.

If you are successful at this stage, you will progress to interview.

Feedback will not be provided at this stage.

Please note you will not be able to upload your CV. You must complete the application form in as much detail as possible. Please do not email us your CV.

Stage 2 Interview

Success Profiles

You will be invited to a remote interview.

Behaviours and Experience will be tested at interview.

The Behaviours tested during the interview stage will be:

• Making Effective Decisions
• Communicating and Influencing
• Working Together
• Managing a Quality Service (Lead)
• Working at Pace

Interviews dates are yet to be confirmed.

Once this job has closed, the job advert will no longer be available. You may want to save a copy for your records.

Location

This role is being offered as hybrid working based at either any of our Core HQs or any of our Scientific Campuses.

We offer great flexible working opportunities at UKHSA and operate using a hybrid working model where business needs allow. This provides us with greater flexibility about how and where we work, to get the best from our workforce. As a hybrid worker, you will be expected to spend a minimum of 60% of your contractual working hours (approximately 3 days a week pro rata, (averaged over a month) working at one of UKHSA's core HQ’s (Birmingham, Leeds, Liverpool, and London) or at one of our scientific campus sites (Colindale, Porton and Chilton).

Our core HQ offices are modern and newly refurbished with excellent city centre transport link and benefit from benefit from co-location with other government departments such as the Department for Health and Social Care (DHSC).

If based at our scientific campus, you will be required to have a minimum of a Counter Terrorism Check security vetting check as a minimum. For meaningful National Security Vetting checks to be carried out individuals need to have lived in the UK for a sufficient period of time. You should normally have been resident in the United Kingdom for the last 3 years as the role requires Counter Terrorism Check (CTC) clearance. UK residency less than the outlined periods may not necessarily bar you from gaining national security vetting and applicants should contact the Vacancy Holder/Recruiting Manager listed in the advert for further advice.

Security Clearance Level Requirement

Successful candidates must pass a standard disclosure and barring security check.

Successful candidates must meet the security requirements before they can be appointed. The level of security needed is Baseline Personnel Security Standard or Counter Terrorism Check. This will depend on the applicant's chosen location.

Eligibility Criteria

External: Open to all external applicants (anyone) from outside the Civil Service (including internal applicants).

Future location

UKHSA is investing in a new state-of-the-art National Biosecurity Centre in Harlow, Essex, which will eventually bring together teams currently based at Canary Wharf, Colindale and Porton Down. For more details, please see: Huge biosecurity centre investment to boost pandemic protection - GOV.UK.

The new facilities will start becoming operational in the mid-2030s, with full completion by 2038. Staff will move in phases as facilities become available. If you're appointed to a role currently based at Canary Wharf, Colindale or Porton Down, please note that we'll continue investing in these sites for the next decade. As we get closer to the transition, we'll provide full information about relocation support available to staff.

Reasonable Adjustments

The Civil Service is committed to making sure that our selection methods are fair to everyone. To help you during the recruitment process, we will consider any reasonable adjustments that could help you. An adjustment is a change to the recruitment process or an adjustment at work. This is separate to the Disability Confident Scheme. If you need an adjustment to be made at any point during the recruitment process you should contact the recruitment team in confidence as soon as possible to discuss your needs.

You can find out more information about reasonable adjustments across the Civil Service here: https://www.civil-service-careers.gov.uk/reasonable-adjustments/

International Police check

If you have spent more than 6 months abroad over the last 3 years you may need an International Police Check. This would not necessarily have to be in a single block, and it could be time accrued over that period.

Internal Fraud check

If successful for this role as one aspect of pre-employment screening, applicant’s personal details – name, national insurance number and date of birth - will be checked against the Cabinet Office Internal Fraud Hub and anyone included on the database will be refused employment unless they can show exceptional circumstances. Currently this is only for External candidates to the Civil Service.

Careers website

Please visit our careers site for more information https://gov.uk/ukhsa/careers

Salary Information

If you are successful at interview, and are moving from another government department, NHS, or Local Authority, the relevant starting salary principles for level transfers or promotions will apply. Otherwise, roles are offered at the pay scale minimum for the grade, but in exceptional circumstances there may be flexibility if you are able to demonstrate you are already in receipt of an existing, higher salary. Pay increases are through the relevant annual pay award for the role and terms.

Higher Executive Officer (HEO)

• £33,422-£40,731 (National)
• £35,587- £43,244 (Outer London)
• £37,749- £45,353 (Inner London)

For Fixed term posts

If you are not currently a civil servant, you will take up the post on a Fixed Term appointment. You may be able to take this role up as a Secondment. If you are an existing Civil Servant, based outside of the UKHSA, you will take up the post as a loan which you will need your department to agree. You cannot take the post up as a fixed term. If you are an existing UKHSA member of staff, you will take up the post as either a level transfer or a temporary promotion as per the UKHSA’s Pay policy.

Feedback will only be provided if you attend an interview or assessment.

Security

Successful candidates must undergo a criminal record check.Successful candidates must meet the security requirements before they can be appointed. The level of security needed is counter-terrorist check (opens in a new window).

See our vetting charter (opens in a new window).People working with government assets must complete baseline personnel security standard (opens in new window) checks.

Nationality requirements

This job is broadly open to the following groups:

• UK nationals
• nationals of the Republic of Ireland
• nationals of Commonwealth countries who have the right to work in the UK
• nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities with settled or pre-settled status under the European Union Settlement Scheme (EUSS) (opens in a new window)
• nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities who have made a valid application for settled or pre-settled status under the European Union Settlement Scheme (EUSS)
• individuals with limited leave to remain or indefinite leave to remain who were eligible to apply for EUSS on or before 31 December 2020
• Turkish nationals, and certain family members of Turkish nationals, who have accrued the right to work in the Civil Service

Further information on nationality requirements (opens in a new window)

Working for the Civil Service

The Civil Service Code (opens in a new window) sets out the standards of behaviour expected of civil servants.

We recruit by merit on the basis of fair and open competition, as outlined in the Civil Service Commission's recruitment principles (opens in a new window).The Civil Service embraces diversity and promotes equal opportunities. As such, we run a Disability Confident Scheme (DCS) for candidates with disabilities who meet the minimum selection criteria.

Diversity and Inclusion

The Civil Service is committed to attract, retain and invest in talent wherever it is found. To learn more please see theCivil Service People Plan (opens in a new window) and the Civil Service Diversity and Inclusion Strategy (opens in a new window).

Apply and further information

Once this job has closed, the job advert will no longer be available. You may want to save a copy for your records.

Contact point for applicants

Job contact :

• Name : Charlene Gwekwerere
• Email : charlene.gwekwerere@ukhsa.gov.uk

Recruitment team

• Email : recruitment@ukhsa.gov.uk

Further information

The law requires that selection for appointment to the Civil Service is on merit on the basis of fair and open competition as outlined in the Civil Service Commission's Recruitment Principles. If you feel your application has not been treated in accordance with the Recruitment Principles, and you wish to make a complaint, in the first instance, you should contact UKHSA Public Accountability Unit via email: Complaints@ukhsa.gov.uk If you are not satisfied with the response you receive from the Department, you can contact the Civil Service Commission: Visit the Civil Service Commission website here.