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Principle Quality Engineer

Mirada MedicalNewcastle upon Tyne, UK

15 days ago

Job type

Full-time

Job description

Who are we?

Mirada Medical creates advanced imaging software that helps clinicians deliver faster, more accurate cancer care. Our tools simplify complex imaging tasks, making it easier for hospitals and clinics to provide timely, high-quality treatment. Trusted worldwide, we’re on a mission to accelerate cancer care and make a real difference to patients and healthcare teams.

The RA QA department is part of the Product Team and supports the company at a corporate level and regionally in both the UK and the US. With the support of the Senior Management Team and Board of Directors, the RA QA department ensures that the company complies with regulatory requirements in all applicable global regions and supports the company to meet the required quality standards and objectives in all areas of the business.

About the Role

This is a senior individual contributor QA role in the company, responsible for owning, operating, and evolving our Quality Management System (QMS) and Information Security Management System (ISMS). You will work cross-functionally across all departments, lead audit readiness, drive continuous improvement, and serve as the company’s Information Security Officer and Management Representative.

This role is ideal for someone who thrives in a high-impact, autonomous environment and wants to shape and influence quality strategy at a company-wide level. It offers significant growth potential for a professional looking to expand their strategic and leadership footprint.

Main Duties and Responsibilities :

Strategic and Functional Responsibilities

Own and continuously improve the company’s QMS and ISMS to ensure compliance with ISO 13485, ISO 27001, and global medical device regulations.
Act as the company’s Information Security Officer, driving a proactive security culture and maintaining regulatory readiness.
Lead and coordinate all internal, external, and customer audit activities, including those with Notified and Certification Bodies.
Plan and estimate QA and ISMS activities and represent QA in company-level planning, resourcing, and budgeting decisions.
Provide quality oversight across all business functions, including product development, post-market activities, and supplier management.
Champion a quality-first mindset throughout the organisation, coordinating training, communication, and awareness campaigns.

Project QA and Cross-Functional Support

Serve as QA lead for product development projects, including :

Reviewing technical documentation

Producing phase review documentation

Supporting RA in regulatory submissions

Guide development teams through risk-based quality decisions and process changes, including regulatory and market-driven adaptations.

Oversee complaint handling and post-market surveillance, including root cause analysis, hazard assessment, and escalation.

Core QA Responsibilities

Own and manage the following processes : Document Control, Change Control, CAPA, Supplier Evaluation and Monitoring, Management Review and Training.

Support and guide process owners in regulatory interpretation, risk-based decision making, and change implementation.

Lead and coordinate internal audits to ensure ongoing QMS and ISMS compliance.

Coordinate and host external audits from Notified Bodies, certification bodies, customers, or partners.

Act as Mirada’s Management Representative (MR).

QA Subject Matter Expert (SME) Responsibilities

Act as SME for

Process Validation

Purchasing and Supplier Management

Management Responsibility

Document Control, Change Control, CAPA, and Complaints

Information Security and Customer Support Processes

Information Security Responsibilities

Maintain and implement ISMS policies and procedures as Information Security Officer with the support of Technical Information Security Officer (TISO) and Chief Information Security Officer (CISO).

Participate in the Information Security Committee.

Monitor security incidents, initiate responses, and ensure documentation of ISMS compliance activities.

Conduct ISMS internal audits and participate in external information security assessments.

Qualifications

Essential

5+ Years experience in QA / RA within a regulated medical device environment

ISO 13485, QMS / ISMS implementation and oversight, ISO 14971, IEC 62304

Internal and external auditing experience

Familiarity with EU MDR, US 21 CFR Part 820

Strong communication skills with the flexibility to engage effectively with diverse audiences

System ownership, root cause analysis, risk assessment, documentation, project leadership, software development familiarity

Strategic thinker, self-starter, cross-functional collaborator, efficiency-driven, pragmatic

Preferred

Experience hosting audits and managing CAPAs

ISO 27001, IEC 62366, MDSAP

Certified ISO 13485 internal auditor or lead auditor

Broader global regulatory experience

A confident and approachable communicator who can effectively challenge ideas while driving progress

Training others in quality or ISMS topics

Ability to demonstrate leadership potential and a scaling mindset

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Quality Engineer • Newcastle upon Tyne, UK