Quality Manager

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.

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, alongside the more traditional manufacturing quality activities that will grow as production scales.

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 Knowledge and Odoo Documents, ensuring documents are current, controlled, and approved with visible signatures. Lead the internal audit programme and 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 in accordance with QMS-11, ensuring gate criteria are met before progression. Approve design inputs and design outputs and maintain the design and development file. Oversee design verification and validation activities, and 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 and manage equipment maintenance schedules. Approve product release and 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 and their implications for Dragon Robotics' devices and QMS. Support regulatory submissions and notified body interactions. Manage vigilance obligations and assess complaints for regulatory reportability. Depending on the candidate's background, this role may encompass the responsibilities of Person Responsible for Regulatory Compliance (PRRC) under EU MDR Article 15.

Supplier and Supply Chain Quality

Manage the approved supplier programme in Odoo, including 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 and 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.