UK Junior Quality Officer

Halma View all jobs

  • Windsor, ON
  • Permanent
  • Full-time
  • 21 days ago
As a global market leader in the world of eyecare, Keeler’s dynamic business creates an exciting opportunity for career development.We are a vibrant, future-facing organisation, with over a century of industry expertise. The highly-trusted Keeler brand supports our consistent revenue growth. We actively foster a diverse, inclusive work environment and continuously seek to drive sustainability across our organisation.Keeler is a part of Halma, a global group of life-saving technology companies focused on growing a safer, cleaner, healthier future for everyone, every day. Employing over 7,000 people in more than 20 countries, Halma has major operations in the UK, mainland Europe, the USA and Asia Pacific. Halma is listed on the London Stock Exchange (LON: HLMA) and is a constituent of the FTSE 100 index.About the roleThe UK Junior Quality Officer is responsible for the effective administration and day-to-day operation of key elements of Keeler’s Quality Management System (QMS), with primary focus on customer complaint handling, deviation management, and controlled processing of design changes through the electronic QMS (eQMS).Reporting to the UK Quality Manager, the role acts as a first-line quality gatekeeper, ensuring quality events are correctly triaged, documented, investigated, and progressed within the eQMS in compliance with ISO 13485, regulatory requirements, and internal procedures. The role supports the wider Quality team and cross-functional stakeholders by ensuring quality data is accurate, timely, and audit-ready.Customer Complaints & Post-Market Surveillance
  • Act as the primary administrator for customer complaints within the eQMS, ensuring complaints are logged, categorised, and triaged in line with regulatory and internal requirements
  • Support and coordinate complaint investigations, including data gathering, root cause analysis, and documentation of outcomes
  • Escalate safety-related complaints for CAPA and vigilance assessment, supporting regulatory reporting where required
  • Perform trend analysis of complaints and support periodic reporting and KPI generation
  • Support customer communication by ensuring clear, compliant, and timely responses are documented and approved
QMS Administration & eQMS Ownership
  • Maintain assigned elements of the Quality Management System, ensuring procedures, forms, and records are current and controlled
  • Act as an eQMS administrator for quality events, ensuring correct workflows, approvals, and traceability are maintained
  • Support CAPA initiation and tracking arising from complaints, deviations, audits, and other quality events
  • Ensure quality records are complete, accurate, and audit-ready
  • Support continuous improvement activities by identifying inefficiencies or recurring issues within QMS processes
Deviations, Nonconformances & Supplier Issues
  • Triaging and administration of internal and supplier deviations through the eQMS
  • Ensure deviations are correctly classified, risk assessed, and progressed to closure
  • Liaise with internal teams and suppliers to ensure timely investigation and corrective actions
  • Maintain oversight of deviation status, ageing, and escalation where required
Design Changes & Change Control
  • Support the administration of design changes and engineering changes through the eQMS
  • Act as a QA representative in the initial triage of change requests, ensuring appropriate quality and regulatory impact assessment
  • Ensure design change records are complete, approved, and traceable, including links to risk management, validation, and documentation updates
  • Support Design Change meetings by preparing, tracking, and closing assigned quality actions
Compliance & Audit Readiness
  • Ensure assigned QMS activities comply with ISO 13485:2016, UK MDR, EU MDR, and applicable global regulations
  • Support internal, supplier, notified body, and regulatory audits by providing accurate records, evidence, and responses related to complaints, deviations, and change control
Key Knowledge & Experience:
  • Experience and working knowledge of Quality Assurance
  • Experience in the Medical Device Manufacturing and Healthcare Industry
  • Usage of Quality Investigational tools e.g. Five Whys Technique, Fish Bone Technique, Pareto, FMEA, Is/Is Not Analysis, Ishikawa, FMEA to identify the true root cause of an event.
  • Sound knowledge of CAPAs (Corrective and Preventative Actions)
  • Ability to confidently provide QA support across the business
  • Working in a medical device manufacturing environment
  • Working knowledge of ISO 13485:2016, MDSAP, Medical Devices Directive (93/42/EEC) and Medical Devices Regulations (EU) MDR 2017/745
  • Experience with Risk Management to ISO 14971
  • Ability to work independently on key projects and mentor other members of the team
  • Strong communication skills and ability to influence internal stakeholders and external customers and suppliers with strong analytical reasoning and demonstrate a hands-on approach to work
  • Must be a team player and capable of participating with commitment and sense of ownership.
About You
  • Attention to detail
  • Planning and organisation
  • Confident presenter
  • Technical competence
  • Problem solving skills
  • Team working
  • Self-reliant
  • Excellent communicator
  • Excellent report writing skills
  • Working to deadlines High standards
  • Numerically competent, with an understanding of statistics.
  • Competent with MS Office, Word, PowerPoint, Outlook, Excel etc.
What We Offer You
  • Competitive Remuneration Package including base Salary, performance related bonus structure, pension scheme, and other associated benefits.
  • The potential to work in collaborative work environment within Keeler and Halma Group
  • Career Development Opportunities within Keeler and Halma Group
Location of the role is Windsor based#LI-SL2Join us in creating and delivering life-changing products and solutions that impact millions of people around the world, helping our customers bring an end to preventable vision loss.

Halma