Quality Manager - Transformative

Location: United Kingdom • Estonia • Remote
Closing date: 01 Oct 2021
Posted: 3 weeks, 4 days ago

To apply, please send your CV to li@transformative.ai

About Transformative

Transformative is a VC-funded medical software company operating in the US, UK, and Estonia. We predict life-threatening medical events so that patients and healthcare providers can prevent them, empowering all people to enjoy longer, healthier lives. Our first product, currently under development, uses machine-learning to predict in-hospital cardiac arrest, which will enable life-saving preventive care for a condition that kills 300,000 patients in the US each year and millions more globally.

Job Description

We are recruiting a quality manager to lead development and implementation of our quality management system. You will work closely with all members of Transformative’s 8-person team, reporting directly to our CTO and collaborating with our R&D team and with quality management consultants who assist our work. Transformative is preparing to obtain ISO 13458 certification, and you will play a critical role in QMS document preparation and internal quality auditing, helping us maintain compliance with US & European software development lifecycle regulatory standards for companies developing software as a medical device.

Responsibilities

Duties will include:

  • Oversee development and implementation of Transformative’s quality management system and related documentation
  • Support compliance with US & European software development lifecycle regulatory standards for companies developing software as a medical device
  • Maintain and update standard operating procedure forms
  • Monitor and improve tracking and control systems
  • Conduct risk assessments, workflow analysis, and internal audits
  • Train employees on quality assurance
  • Investigate and document non-conforming events and oversee corrective actions
  • Liaise with external inspectors, helping Transformative obtain ISO 13458 certification

Ideal Candidate

Required:

  • 2-10+ years experience in medical device quality management, ideally working with software as a medical device
  • Ability to manage multiple projects, prioritize goals, and meet project deadlines
  • Strong written and oral communication skills
  • Collaborative approach when coordinating with internal and external stakeholders who have varied backgrounds and expertise

Preferred:

  • Experience with ISO 14971, ISO 13485, ISO 62304 and other global regulatory requirements and quality standards
  • Experience maintaining quality assurance in an agile-SCRUM environment
  • Degree or certification in relevant field
  • Experience preparing for submissions for FDA de novo clearance and EU design dossiers

Company Values

At Transformative, we cultivate each employee's creativity and wellness, inspiring collective excellence. As individuals and as a company, we live by the following values:


1) We put patients first, always.
2) We hold ourselves to the highest standards of integrity in everything we do.
3) We thrive when tackling complex problems that demand simpler solutions.
4) We scrutinize ideas while supporting each other.
5) We overcome obstacles with grit.
6) We always strive to make our team more diverse, inclusive, and equitable.
7) We embrace continuous learning as fuel for exceptional people, teams, and products.
8) We achieve goals efficiently by acting with strategy and focus.
9) We treat our customers as true partners, collaborating toward mutual success.
10) We passionately believe Transformative AI can help the world enter a new era of Predictive Medicine.

Vacancy Details

  • Full-time position
  • Location: Remote, working from US, UK, or Estonia
  • Start Date: ASAP
  • Salary: commensurate with experience, including company stock options

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