Quality System Administrator
Created by email@example.com on 5/27/2022 10:02:36 AM
Job Title: Quality System Administrator
Reports to: Quality Manager
Start Date: June 2022
Hours of Work: 37.5 hours per week (full-time, 6-month probation)
Salary: £28-35k PA
Please send your CV and a cover letter explaining what you can bring to MediSieve to firstname.lastname@example.org.
Imagine a world where doctors can target and remove infected cells, pathogens, toxins, or even viruses directly from a patient’s bloodstream. At MediSieve we are working towards bringing this dream into a reality. Our Magnetic Blood Filtration System is a device-therapeutic combination that filters harmful substances from the bloodstream using magnetic forces.
If you’ve always dreamt of making a global impact, MediSieve is the place to be! The platform nature of our technology enables us to make a difference in treating humanity's most serious diseases, with the first product targeting hyperinflammation in conditions such as COVID-19, Sepsis, and Cytokine Release Syndrome. You have the opportunity to join our diverse, energetic, and fun team at the most exciting time – just before our clinical trials begin!
As Quality System Administrator you will fulfil a key role in the delivery of a new Medical Device to the market. It is an essential requirement that we have a certified Quality Management System (QMS) prior to launching our product, and every process required by the international standard ISO 13485 must be defined and implemented to achieve this. We are in the process of implementing an electronic database system to manage all our quality processes and this role is key to fulfilling that goal.
What You’ll Be Responsible for
- Assisting in the configuration of our MediSieve QMS database utilising the Autodesk Fusion 360 Manage platform
- Authoring work instructions to support the QMS processes
- Preparing data and files for upload of new and existing documents, records, and product data
- Providing expert support to users of MediSieve QMS
- Tracking quality processes to ensure timely completion and alignment with KPIs
- Creating reports from the MediSieve QMS to provide meaningful monitoring and measurement data to process owners and Senior Management
What We Look for in a Candidate
- Exceptional attention to detail
- Familiarity with the principles of quality management
- Worked under a certified QMS
- Previous experience of database management
- Relevant qualifications
Not Essential, but Helpful
- Previous experience in a biotech or medical device company
- Designing and implementing an ISO13485 compliant QMS
- eQMS/PLM experience
- Familiarity with risk management and the role of quality in managing risk
- Audit experience
You’ll Love This Job if You Are:
- Enthusiastic about our mission
- Team-oriented, fun and have excellent interpersonal skills
- Remote work
- 3% Company pension
- 25 days holiday
- Share options scheme
- A vibrant community of Imperial College’s Translation & Innovation Hub
Diversity Commitment: We believe that diversity enables us to see situations from different points of view, leading to ideas and insights which would otherwise be missed. We are focused on building an inclusive team of people of all backgrounds, experiences, abilities, and perspectives. We are diverse in gender (58% women), origin (6 nationalities), and economic background. Everyone is welcome — there will be no judgement towards things that make you You!