Description du poste
PLEASE READ BEFORE APPLYING
Only apply if you have hands-on experience implementing or maintaining a quality management system and have worked directly with ISO 13485 and/or ISO 14971 in healthcare, medical devices or digital health. Training or certification alone is not sufficient, you must be able to explain your contribution and demonstrate practical outcomes.
About the role
VivaFemini is building an integrated women’s health ecosystem that connects digital health tools, trusted information and clinical services to support women across every stage of life.
We are looking for a Quality & Patient Safety Manager to lead the implementation and ongoing improvement of VivaFemini’s quality and safety framework.
You will work across Clinical, Product, Engineering, Customer Experience and Operations to embed practical controls, strengthen accountability and build a culture of quality, patient safety and continuous improvement.
Key responsibilities
1. Quality management and governance
Coordinate implementation of the agreed quality and safety roadmap.
Maintain quality policies, procedures, document registers and review schedules.
Support departments to translate policies into practical working processes.
Prepare quality and safety meeting papers, dashboards and action trackers.
Monitor agreed actions and escalate delays or significant concerns.
Support management reviews and maintain evidence of decisions and follow-through.
2. Patient safety and risk management
Facilitate identification and assessment of risks across digital products and clinical services.
Maintain risk registers and hazard logs with relevant clinical, product and engineering colleagues.
Track risk controls, responsible owners and evidence of implementation.
Coordinate incident, near-miss and safety concern reporting.
Support investigations that identify contributing factors and practical improvements.
Escalate significant concerns promptly through agreed channels.
3. Digital product and clinical quality
Work with Product, Engineering, Clinical and Customer Experience teams to integrate safety considerations into development and service delivery.
Coordinate quality and safety reviews of relevant features, workflows and changes.
Check that required clinical reviews, testing evidence and approvals are recorded.
Support controlled review and updating of clinical content and pathways.
Help monitor emerging concerns involving AI outputs, usability, referrals and patient information.
Maintain links between complaints, incidents, product risks and improvement priorities.
4. Audit and continuous improvement
Develop and coordinate a proportionate internal audit programme.
Review whether agreed processes are being followed and are effective.
Track corrective actions and verify that completed actions address the underlying problem.
Analyse complaints, incidents and performance information for recurring themes.
Support departments to plan, implement and evaluate improvements.
Share learning across teams.
5. Staff capability and safety culture
Coordinate quality and safety induction and role-specific training.
Facilitate practical workshops, learning discussions and incident simulations.
Encourage staff to raise concerns and participate in improvement.
Support managers to respond fairly and constructively to reported problems.
Assess practical understanding and identify further development needs.
Ensure staff receive feedback on concerns raised and resulting changes.
Essential requirements
Relevant degree in nursing, medicine, another healthcare profession, health sciences, quality management or a related discipline with active practicing license.
Demonstrable experience in healthcare quality, patient safety, clinical governance or quality assurance within a digital health organisation.
Practical experience implementing or maintaining quality processes.
Experience with incident review, risk assessment, audit or corrective action.
Ability to turn policies and standards into usable operational processes.
Confidence working across clinical, technical and operational teams.
Strong facilitation, report-writing, data interpretation and action-tracking skills.
Evidence of delivering improvements and checking whether they worked.
Sound judgement, professional integrity and confidence to escalate concerns.
Desirable requirements
Experience in digital health, telehealth, health technology or healthcare software.
Familiarity with ISO 13485, ISO 14971, software clinical safety or related frameworks.
Quality improvement, internal auditor or patient safety training.
Experience with clinical content governance, usability or AI-enabled health products.
Experience in women’s health or reproductive healthcare.
Experience supporting a growing organisation to establish new systems.
Compensation and benefits
Competitive salary based on experience, pension contributions, HMO coverage, and professional development opportunities.
How to apply
Send your CV to hr@vivafemini.org with the subject line Clinical Quality and Patient Safety Manager , or apply through LinkedIn. No cover letter is required.
Please apply only if you meet the essential requirements, including hands-on experience with ISO 13485 and/or ISO 14971. Your CV must clearly demonstrate this experience. Applications that do not meet these requirements will not be progressed.
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