Assistant Quality Coordinator

1 month ago

Cambridge, United Kingdom electronRx Full time

**Position Title**:Assistant Quality Coordinator

**Reports to**:Quality and Compliance manager

**Location**: Cambridge

**Salary**: £30-35k per annum

**Who is electronRx?**

We are a deep tech company, based in Cambridge, UK, with a fast-growing team. Daily we are driving the development and commercialisation of our novel disease management and hospital patient flow technologies, that pave the way for personalised digital medicine.

As a group of interdisciplinary scientists, engineers and commercial professionals,, we hold an inherent appreciation for the value created by diverse perspectives and are proud to be an enjoyable, open and respectful work environment for ALL, regardless of background or identity.

At eRx, we are committed to:

- Highest quality innovation; solving real problems with scientific rigour and evidence-based value
- Improving healthcare for everyone, everywhere through scalable technologies that remove barriers to access
- Thinking outside the box with a fresh, deep tech approach that drives creative solutions to complex problems
- Putting the human in health tech with patient-centric design built by people who care

We offer a hybrid work environment with a combination of in-office and remote working.

**Our Mission**

We are building the interface between technology, the human body and healthcare organisations that will transform how we deliver healthcare and treat disease.

**Our Values**

Our core values are the organic foundation of everything that we do here at electronRx; how we work together, how we develop products and how we present ourselves to customers and the world.

We want partners and customers to know where they stand with us as a team. If what motivates us motivates you too, then we can do great things together.

As the electronRx team, we
- Empower - Each other as a team, patients to take back control over their health, and health professionals with knowledge that cuts through the noise.
- Don’t compromise on science - If it’s not rigorously scientific and evidence-based, it’s not good enough. Always, but especially in healthcare.
- Fail, and fail again - The course of true innovation never did run smoothly. When you’re operating on the frontlines of tech discovery, failure is an inevitable and necessary part of the process.
- Care - We’re experts in our respective fields who have chosen to join this team because we see the potential here to change people’s lives on a planetary scale for the better

**The Role**:
This position is responsible for managing the QMS within electronRx to ensure that the company operations are compliant with the requirements of ISO 13485:2016 and all applicable medical device regulations as referenced in the Quality Manual.

**Essential Duties and Responsibilities**:

- Ensure that the processes needed for the QMS are documented, effectively implemented and remain compliant with the current requirements of ISO 13485:2016 and all associated regulatory requirements.
- Identify and manage improvements to the QMS required by changing standards, regulatory requirements, supplier and customer requirements.
- Manage and execute internal audits, except in areas for which this role is solely responsible.
- Host Notified Body and customer audits.
- Manage the supply chain: ensure that suppliers are appropriately assessed and monitored, that sub-contract manufacturer’s are complying with electronRx requirements and all product related records are being completed and provided to electronRx in a timely manner.
- Manage the monitoring of key performance indicators for electronRx to provide evidence of process and product conformity and provide data for analysis at the Management Review meetings.
- Manage the corrective and preventive action process to ensure that non-conformities are identified and appropriately addressed to prevent recurrence and improvements are effectively introduced into the business.
- Manage all Post Market Surveillance, Fields Safety Corrective Action and Field Safety Notice activities including communication with and reporting to Competent Authorities.
- Provide a point of contact for customers with regard to Quality and Regulatory matters.

**Qualifications/Competencies/Position Requirements**:

- Knowledge, Skills, and Abilities:_
- Good understanding of the requirements of ISO 13485, UK MDR, EU MDD and EU MDR and proven ability to develop and maintain the QMS.
- Experience with medical device manufacturing and associated supporting process and record keeping.
- Excellent interpersonal, communication and training skills.
- Experienced ISO 13485 Auditor.
- Good data analysis and presentation skills.
- Highly developed organisational skills and ability to prioritise
- , plan and execute improvement projects.
- A competent self-manager, able to motivate self and others.
- Higher Education and Experience:_
- At least 3 years’ experience working in a Quality role in a medical device manufacturing business w

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