Quality Assurance Specialist - Cardiff, United Kingdom - MyHealthChecked plc

Description

Job title:
Quality Assurance Specialist


Location:
Cardiff, Wales


Contract Type:
Full-time/Permanent


Salary/Benefits:
Up to £45k (depending on skills/experience) + 26 days holiday including birthday + Private Health Care


Working Hours:
Monday to Friday


About the Company:

MyHealthChecked Plc is a listed business (


AIM:
MHC) and the home of Concepta Diagnostics, an ambitious creator of at-home testing platforms and information.

Under its MyHealthChecked brand, we want to make good health and wellness the most accessible it's ever been, and our commercial plans are positively timed to coincide with consumer acceptance and desire for at-home testing services.

To position us for this growth phase, our fast-paced company has achieved over £16m of revenue in 2021 and £2.4m EBITDA, and is poised to launch further at-home tests in early 2023.

Concepta Diagnostics has ambitious plans to build innovative solutions that underpin its on-line Direct to Consumer, retail, and B2B channel growth, with evolution into SaMD.

About the role:

This is an exciting opportunity for a Quality Assurance Specialist to join a growing team and provide Quality Assurance support across an expanding portfolio of diagnostic tests and services in the consumer health space.

We are seeking individuals who are passionate about Quality Assurance and understand the importance of QA in the delivery of healthcare products and services.

What we are looking for:

A scientific qualification and experience working within an ISO of GMP-regulated environment within a QA role is essential, and ISO 13485 experience is particularly desirable.

You will have a real passion for Quality Management and understand the QA process for the management of IVD products and services, and the paperwork required in relation to starting materials, in-process components and release of final kits.

Role & Responsibilities:

• In conjunction with the QA/RA Lead, support the development and implementation of the Quality Management System in accordance with all applicable regulations and standards according to business needs and the maintenance thereafter
• Implement the Quality Plans and Objectives to meet the needs of business including an effective Quality Management Review process
• Implement and maintain appropriate QA control over validation plans and their documentation ensuring relevance to the QMS.
• Support external regulatory consultants in preparation and documentation for regulatory submissions
• To be the internal support on regulatory matters, communicating with our QARA experts to advise management on standards and protocols set by external bodies, and supporting the achievement of those
• To promote a Qualityfocused culture throughout the business, ensuring relevant Quality documentation is available to the appropriate laboratory users
• Provide monthly report on Quality metrics greed with the QA/RA lead the effectiveness of the QMS and any need for improvement
• In conjunction with the QA/RA Lead, support the development and implementation a system of internal audit throughout the business and supervise the process for corrective action.
• To liaise with third party suppliers to ensure that the quality standards defined by relevant compliance and accreditation bodies are maintained
• To support external supplier audits and implement and maintain an effective suppler management process and maintenance of quality agreements
• To support the QA/RA Lead and where appropriate represent the company to external bodies involved in assessing the quality management system, facilitating any audit requests as required such as BSI and MHRA.
• To support the implementation and lead the ongoing management of the digital QMS (QPulse).

Quality Management System Administration & Training:

• Ensure any continuous improvement programs comply with QMS and receive appropriate verification, validation, and risk analysis.
• Support the delivery of the nonconformance and CAPA management system in the business and report on progress.
• Responsible for the administration customer complaints and subsequent root cause analysis of any issues and the recommend corrective action.
• Support managers to maintain training matrix

• Creating document templates

• Converting information from project teams into userfriendly documents
• Numbering and labelling documents for identification and reference
• Digital filing and distribution of documents to project team members and stakeholders
• Reviewing documents and making revisions for accuracy
• Manage and coordinate document control via the paper based QMS and SharePoint
• Contribute to the drafting of documentation, manage the review and approval of documents, including SOPs, WIs, and forms within the QMS
• Provide administrative support to users of the QMS, assisting with configurations using the internal platform.
• Generate reports from the QMS to provide meaningful monitoring and measurement dat