Quality Manager

Location: 

• Remote role based in either UK or Ireland
• Applicants must be currently living in either UK or Ireland 
  Applicants must hold relevant work permits/Visa for UK or Ireland - regrettably we are unable to offer Work/ Visa sponsorship  or relocation for this role. 

Travel Friendly role 

• This position comes with a travel requirement of around 20 – 30 days per year (possibly more as we grow). 
• You'll be heading to our sites in Ireland, UK (Kidlington and Exeter), Canada, USA etc. This includes audit visits, site visits, company meetings etc. 
• To make travel easier, we’d ideally like you to be based within easy reach of an airport, ensuring smooth trips that fit around your work and availability. 

About this Role

• We are hiring a Quality Manager to lead and mature our quality management system across medical device software development and deployment.
  
• You will support customer-facing product development, internal medical software teams (AI and non-AI), and help shape Deciphex's regulatory roadmap for global markets.
  
• This role is ideal for someone who thrives in a cross-functional environment, is passionate about quality and technology, and is excited by the opportunity to help shape our compliance infrastructure.

Responsibilities:

• Serve as Management Representative for the ISO 13485 Quality Management System (QMS).
• Establish, implement, and maintain a robust QMS to meet ISO 13485, FDA 21 CFR Part 820, EU MDR/IVDR, and other international regulatory requirements.
• Provide quality and regulatory support to cross-functional teams including product, engineering, AI systems, and customer project teams throughout the product lifecycle.
• Lead internal and external audits, including Notified Body audits, supplier audits, and regulatory inspections.
• Oversee quality processes including design controls, document control, CAPA, training, complaints, risk management, change control, and supplier quality.
• Support preparation and submission of regulatory filings and technical documentation (FDA, CE, UKCA, and other markets).
• Collaborate with the AI development team to design and implement an Artificial Intelligence Management System (AIMS) aligned to ISO/IEC 42001.
• Oversee quality elements within the AI software development system, including material qualification and final product release, where applicable.
• Lead complaint management and post-market surveillance processes, ensuring timely resolution and trend analysis.
• Champion risk management across design and development in line with ISO 14971, including risk analysis, mitigation, and usability risk considerations.
• Support supplier evaluation and qualification activities to ensure materials and services meet quality and regulatory expectations.
• Drive continuous improvement initiatives using tools such as Lean, Six Sigma, FMEA, and root cause analysis.
• Provide training and mentorship on medical device requirements, QMS processes, standards, and best practices.
• Stay informed on emerging regulations, industry standards, and AI governance trends.
• Training required for the role may include ISMS, GLP, DocuSign, and GDPR awareness.
• Managing all or part of the Quality team, including: Recruitment and Line management of team members

Required Skills and Experience:

• Bachelor’s degree in Life Sciences, Engineering, or related discipline.
• 5+ years’ experience in Quality Management or regulatory affairs role within the medical device/ clinical trials or IVD software sector.
• Demonstrated knowledge of ISO 13485, FDA 21 CFR 820, ISO 14971, IEC 62304, and regulatory requirements for software and IVDs including AI.
• Implemented a QMS to ISO 13485:2016, leading the certification process.
  
• Proven experience supporting product development teams, including AI/ML and traditional software-based medical technologies, diagnostic devices and SaMD
• Hands-on experience with internal audits, supplier management, CAPA, complaint handling, and document control systems.

Desirable Skills and Experience

• Experience of managing 510(k) applications for FDA Class II devices and/or Class IIb or III for CE marking and UKCA.
• Experience with digital pathology systems and diagnostic AI algorithms.
• ISO 13485 Lead Auditor certification or equivalent
• Experience with ISO/IEC 42001 or AI risk governance frameworks

Soft Skills

• You are a natural problem-solver who brings structure, clarity, and confidence to regulated environments.
• You thrive in cross-functional teams and can clearly communicate quality and compliance expectations to technical and non-technical stakeholders.
• You are highly organized and capable of balancing strategic oversight with hands-on execution.
• You’re curious, proactive, and motivated by opportunities to improve systems and outcomes.
• You value collaboration, accountability, and continual learning.

What are the benefits of working with Deciphex?

• Competitive salary with performance based annual increments.
• Healthcare benefits
• Competitive annual leave
• A true sense of meaning in your work by contributing to better patient outcomes.
• The opportunity to work alongside a world-class high performing team in a hyper-growth startup environment.
• A chance to work on exciting, challenging and unique projects.
• Regular performance feedback and significant career growth opportunities.
• A highly collaborative and supportive multi-cultural team.

 About us:

Through the work that we do, the team at Deciphex helps pharma to accelerate the process of essential drug development and helps patients to get timely and accurate diagnosis.

Founded in Dublin in 2017, Deciphex has scaled rapidly to a team of over 190 people and counting who are providing software solutions to address the pathology gap in research pathology and clinical areas. We have offices in Dublin, Exeter, Oxford, Toronto and Chicago and are expanding our team throughout the world.

We are software developers, clinical specialists, AI engineers, operations professionals and so much more, all working as one team to support our customers and patients.  Our team culture is built on trust. We give our team the space they need to deliver results and the environment to ensure they can enjoy doing it.

Read more about Deciphex here and more about our incredible team on our Careers Page here

Deciphex is an equal opportunities employer, and we are committed to the principle of equality. All qualified applicants will be considered for employment without regard to age, race, religious beliefs, political views, gender identity, affectional or sexual orientation, national origin, family or marital status (including pregnancy), disability, membership of the travelling community or any other classification protected by applicable law.