Skip to Content

We are hiring

Our Job Offers

Quality Manager

1 open position

About Dragon Robotics

Dragon Robotics designs and manufactures precision medical devices and instruments for clinical and laboratory use. Our current flagship product, C-Vit, is a complex electromechanical instrument for the assisted reproductive technology sector. We are a small, engineering-led team at an exciting stage: a functioning QMS is in place, our Stage 1 ISO 13485 audit is imminent, and we are progressing toward CE marking under EU MDR 2017/745.

We run our QMS entirely on Odoo — document control, CAPA, supplier management, manufacturing quality checks, calibration register, and training records all live there. Experience with or enthusiasm for ERP-based QMS management is essential.

The Role

This is a hands-on quality management role, not a governance role. You will own the QMS day-to-day and be the primary point of accountability for regulatory compliance as we move from development into manufacturing and eventual market launch.

A significant portion of the near-term workload is quality oversight of design and development — stage gate reviews, design V&V, traceability, and technical file management — alongside the more traditional manufacturing quality activities that will grow as production scales. The right candidate is equally comfortable in a design review room and on the production floor.

Key Responsibilities

QMS Management

  • Own, maintain, and continuously improve the QMS in compliance with ISO 13485:2016 and EU MDR 2017/745
  • Manage all QMS documentation in Odoo, ensuring documents are current, controlled, and approved
  • Lead internal audit programme; prepare for and support external audits including LRQA Stage 2 and beyond
  • Chair Management Review meetings; prepare input packs and track actions to closure
  • Manage the CAPA process end-to-end in Odoo

Design and Development Quality

  • Participate in and support stage gate reviews; ensure gate criteria are met before progression
  • Approve design inputs and design outputs; maintain the design and development file
  • Oversee design verification and validation activities; review and approve V&V protocols and reports
  • Interface with the software and engineering teams on IEC 62304 compliance and software validation

Manufacturing Quality

  • Define and maintain quality check acceptance criteria in Odoo manufacturing orders
  • Manage incoming inspection, nonconforming product controls, and supplier quality performance
  • Own the calibration register in Odoo; manage equipment maintenance schedules
  • Approve product release; ensure batch records are complete before dispatch

Regulatory and Compliance

  • Maintain awareness of EU MDR 2017/745, UK MDR 2002, and ISO 13485:2016 requirements
  • Support regulatory submissions and notified body interactions
  • Manage vigilance obligations; assess complaints for regulatory reportability
  • The role may encompass the responsibilities of Person Responsible for Regulatory Compliance (PRRC) under EU MDR Article 15, depending on the candidate's background

Supplier and Supply Chain Quality

  • Manage the approved supplier programme in Odoo; conduct supplier evaluations and re-evaluations
  • Define component criticality and incoming inspection requirements in Odoo product records
  • Monitor supplier performance and drive corrective action where required

Training and Competence

  • Maintain training records in Odoo eLearning; manage certification of mandatory training
  • Develop and deliver QMS awareness and role-specific quality training
  • Support on-the-job competence assessments for manufacturing and testing tasks

Essential Requirements

  • Proven experience in a quality management role within medical devices or life sciences, with direct responsibility for an ISO 13485 QMS
  • Working knowledge of EU MDR 2017/745 and its practical requirements — technical files, clinical evaluation, vigilance, and notified body processes
  • Experience with design controls and quality oversight of product development, not only manufacturing
  • Familiarity with software validation principles (§4.1.6 and §7.5.6) and IEC 62304 at a process level
  • Confidence working with digital QMS tools — experience with Odoo or other ERP-based quality systems is strongly preferred
  • Excellent written communication; able to produce clear, concise QMS documentation to audit standard
  • Strong analytical skills; comfortable interpreting quality data, nonconformance trends, and audit findings
  • Organised and self-directed — this is a small team and the role requires initiative and ownership

Desirable

  • Eligible or qualified to act as PRRC under EU MDR Article 15
  • Experience supporting a Stage 2 ISO 13485 certification audit
  • Familiarity with IEC 62304, IEC 62366-1, and ISO 14971
  • Relevant qualification in Quality Management, Regulatory Affairs, Engineering, or a related scientific discipline
Pembroke Dock, United Kingdom