CoMind on cord

CoMind

Director of Quality Assurance

External position
London, UK
Hiring internally for CoMind?
MedTech · Hardware · Machine Learning and AI
Our mission is to transform patient care with non-invasive neural sensors.
Posted
6 days ago
Checked
cord regularly checks that external positions are still open
2 days ago

Skills & Experience

Job roles: Quality Assurance
Experience level: Lead, Leadership
Core skills considered: Manual Testing, Automated Testing
Other skills considered: Functional Testing

Logistics

Base salary: £120K - £140K
Employment type: Permanent
Remote working: Hybrid (up to 1 remote day p/w)
Visa sponsorship: Not available

Job Description

As Director of Quality Assurance, you will lead our Quality function across three core areas: the quality management system, design quality assurance including software quality assurance, and supplier quality assurance including QC activities. As we approach on-market release, you will also prepare the QMS for customer facing activities including post-market surveillance and complaint handling.

This is a player-coach role: hands-on leadership rather than pure people-management. You will set direction and develop the team, but you will also write procedures, make decisions, and stay close to the product and organisation needs. You will work as a direct partner to our engineering teams and alongside our dedicated Regulatory Affairs leadership. Regulatory is not part of this role, but a function you will collaborate closely with.


Responsibilities

  • Team Leadership: Lead and develop our existing Quality team, instilling and maintaining a high performance culture.
  • Ensure the CoMind QMS complies with the FDA QMSR (21 CFR Part 820, harmonised with ISO 13485) and 21 CFR Part 11 for electronic records and signatures, while remaining customer focused and aligned with business needs.
  • Audit Leadership: Lead our annual ISO 13485 certification audit, FDA inspection readiness and own the internal, supplier, and customer audit programmes.
  • Design Quality Assurance: Oversee design controls and design transfer to manufacturing including the DHFs and DHRs, ISO 14971 risk management, IEC 62366 useability, UDI requirement, and quality assurance across an integrated product spanning electronics, optics, and software.
  • Provide oversight and guidance on software development processes including IEC 62304 software development processes, Software as Medical Device (SaMD) classification, and FDA's SaMD/AI-ML guidance.
  • Cybersecurity: Provide oversight and guidance on cybersecurity aspects impacting product and business processes, including FDA's premarket cybersecurity guidance (Section 524B)
  • Supplier & Manufacturing Quality: Lead supplier qualification, supplier audits, and manufacturing quality as we build toward commercial production. Work with suppliers to ensure effective Quality Assurance and Quality Control processes are implemented. Establish processes for maintaining Device Master Records, and transfer of batch records to CoMind.
  • Post-Market Quality: Create the post-market side of the QMS from the ground up as we launch, including complaint handling, product analytics, and on-market quality processes
  • Work with the RA function to compile Periodic Safety Update Reports (PSUR), vigilance reporting / MDR reporting, or field corrective actions/recalls in line with EU MDR/FDA obligations.
  • Provide oversight and guidance on clinical evaluation / clinical data quality.

Skills & Experience

  • Extensive leadership experience in Quality Assurance within an ISO 13485 environment including product design, manufacturing and commercial customer-facing operations
  • A strong track record of building and managing high-performing Quality teams.
  • Expert command of the core Quality toolkit: QMS, ISO 13485, design controls, ISO 14971 risk management, CAPA, validation, and supplier quality.
  • Experience hosting and leading audits, including annual certification audits. Preferred audit certifications (ASQ CQE/CQA/CMQ-OE, RAC, Lead Auditor certification)
  • Background in medical devices, ideally complex or integrated products. Strong candidates from diagnostics, IVD or pharma will also be considered.
  • Experience in software-intensive / connected-devices
  • Working knowledge of FDA / EU MDR and UK CA regulatory frameworks
  • SaMD/software quality experience, human factors, or cybersecurity awareness
  • A hands-on operator. You are comfortable writing SOPs and making decisions yourself, not just directing others.
  • A record of staying and building - you are motivated by the journey and the chance to shape a function

Company Benefits

  • Generous stock options
  • Breakfast and snacks provided
  • Weekly lunches
  • 25 days holiday (+ bank holidays)
  • Hybrid working
  • Quarterly work-from-anywhere policy
Director of Quality Assurance at CoMind
Position posted 6 days ago

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Starling Bank on cord

Starling Bank

Full Stack Engineer (ML Ops)

London, UK
FinTech · Banking · Finance
A better bank for everyone
Active
over 6 months ago
Responds to
0% of requests
Responds in
1h 55m
Requests
7 pending

Skills & Experience

Job roles: Full Stack
Experience level: Mid, Senior
Core skills considered: Java, React, Redux, AWS, JavaScript

Logistics

Base salary: £70K - £110K
Employment type: Permanent
Remote working: Hybrid (up to 2 remote days p/w)
Visa sponsorship: Not available

Job Description

Starling is the UK’s first and leading digital bank on a mission to fix banking! Our vision is fast technology, fair service, and honest values. All at the tap of a phone, all the time.

Starling is the UK’s first and leading digital bank on a mission to fix banking! We built a new kind of bank because we knew technology had the power to help people save, spend and manage their money in a new and transformative way.

We’re a fully licensed UK bank with the culture and spirit of a fast-moving, disruptive tech company. We’re a bank, but better: fairer, easier to use and designed to demystify money for everyone. We employ more than 3,000 people across our London, Southampton, Cardiff and Manchester offices.

Our technologists are at the very heart of Starling and enjoy working in a fast-paced environment that is all about building things, creating new stuff, and disruptive technology that keeps us on the cutting edge of fintech. We operate a flat structure to empower you to make decisions regardless of what your primary responsibilities may be, innovation and collaboration will be at the core of everything you do. Help is never far away in our open culture, you will find support in your team and from across the business, we are in this together!

The way to thrive and shine within Starling is to be a self-driven individual and be able to take full ownership of everything around you: From building things, designing, discovering, to sharing knowledge with your colleagues and making sure all processes are efficient and productive to deliver the best possible results for our customers. Our purpose is underpinned by five Starling values: Listen, Keep It Simple, Do The Right Thing, Own It, and Aim For Greatness.

Hybrid Working

We have a Hybrid approach to working here at Starling - our preference is that you're located within a commutable distance of one of our offices so that we're able to interact and collaborate in person. We don't like to mandate how much you visit the office and work from home, that's to be agreed upon between you and your manager.

Our Data Environment

Our Data teams are excited about the value of data within the business, powers our product decisions to improve things for our customers and enhance effective and agile decision making, regardless of what their primary tech stack may be. Hear from the team in our latest blogs or our case studies with Women in Tech.

We are looking for talented data professionals at all levels to join the team. We value people being engaged and caring about customers, caring about the code they write and the contribution they make to Starling. People with a broad ability to apply themselves to a multitude of problems and challenges, who can work across teams do great things here at Starling, to continue changing banking for good.

Requirements

We have built our entire banking platform in house and mostly in Java. We are looking for people who want to work on building the tooling that is used by our engineers on a daily basis.

We are looking for people who are truly full stack, and are as comfortable polishing their javascript front end as they are debugging the innards of their java applications database interactions, or standing up infrastructure with terraform. We are looking for people who can:

  • Design REST apis.
  • Code backend services, ideally using Java, or another other server side compiled language.
  • Develop modern front ends, ideally using React and Redux.
  • Get their code into the cloud and support it there, ideally on AWS.
  • Believe in clean coding, simple solutions, automated testing and continuous deployment.
  • Like to take ownership of a feature from the original idea through to live.
  • Think (like us) that a small number of empowered developers is the right way to deliver software.

Company Benefits

  • 33 days holiday (including flexible bank holidays)
  • An extra day’s holiday for your birthday
  • 16 hours paid volunteering time a year
  • Part-time and/or flexible hours available for most roles
  • Salary sacrifice, company enhanced pension scheme
  • Life insurance at 4x your salary
  • Hybrid/remote working
  • Private Medical Insurance with VitalityHealth including mental health support and cancer care. Partner benefits include discounts with Waitrose, Mr&Mrs Smith and Peloton
  • Generous family-friendly policies
  • Varied social groups set up and run by our employees
  • Perkbox membership giving access to retail discounts, a wellness platform for physical and mental health, and weekly free and boosted perks
  • Access to initiatives like Cycle to Work, Salary Sacrificed Gym partnerships and Electric Vehicle (EV) leasing

Full details are available on our careers site

Interview Process

Interviewing is a two way process and we want you to have the time and opportunity to get to know us, as much as we are getting to know you! Our interviews are conversational and we want to get the best from you, so come with questions and be curious. In general you can expect the below, following a chat with one of our Talent Team:

  • Stage 1 - 30 mins with one of the team
  • Stage 2 - Take home challenge
  • Stage 3 - 90 mins technical interview with two team members
  • Stage 3 - 45 min final with an executive and a member of the people team
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