Quality Assurance Specialist (Med Devices and IVDs) in Bingham

The Role: Quality Assurance Specialist (Med Devices and IVDs)

Must have experience working in Medical Device & IVD industry

Medichecks launched the UKs first direct-to-consumer blood testing company in the UK and created a market where there was none.

As well as the continued growth of our B2C business we now see considerable opportunity to grow in the B2B and B2B2C space through our technology platform, Plasma.

Our vision is to be part of everyone’s journey to better health.

At Medichecks we’re building a healthcare platform for the future.

We’re a team of medics, designers, engineers and communicators who are intent on bringing our vision to life.

We’d like to hear from people who want to use their skills and knowledge to improve peoples’ lives and help us create real change in the way that blood testing and insights can be delivered.

We are proud to be an employer of choice: listed by Best Company in the top 100 SME companies to work for in the UK, top 50 in the East Midlands and top 10 Health and Social Care.

Purpose of this role

This is a new position within a growing team contributing to the quality culture of Medichecks.

This role will offer development opportunities as you grow into the role and would be perfect for a candidate who already has quality experience and wants to develop their career within the industry even further.

The primary function of this role is to support the Quality and Regulatoryteam on a day-to-day basis to ensure coordination and compliance of quality activities across all areas of the business, ensuring policies and procedures are fully documented to support compliance and regulatory requirements.

A key element of this role will be focused on the co-ordination of Quality Assurance activities across all areas of the business whilst supporting the management of Medichecks Quality Management System.

You will champion continuous improvement of Medichecks processes and contribute to the management and implementation of quality initiatives.

• Role and responsibilities
• Support the maintenance, continual improvement, and audit readiness of the ISO 13485 accredited Quality Management System (QMS).
• Ensure compliance with national and international standards and legislation, including ISO 13485 and ISO 27001.
• Manage Corrective and Preventive Actions (CAPA) and non-conformances from logging through to resolution, including root cause analysis and effectiveness checks.
• Prepare and present monthly trend reports on CAPAs and non-conformanities to senior stakeholders.
• Actively monitor and remain up to date with changes to industry standards, regulations, and guidance.
• Review, update, and maintain Standard Operating Procedures (SOPs) to ensure QA processes are current, accurate, and clearly communicated to relevant teams.
• Act as a Subject Matter Expert (SME) for the QMS, advising stakeholders on best practices and creating and delivering educational materials to support the wider business and promote a strong quality culture.

Administer and manage change controls within the Q&R team from initiation to sign-off.

• Support the preparation and execution of internal and external audits, contributing as an SME where required.
• Act as a member of the internal audit team completing annual QMS internal audits
• Complete supplier qualification and periodic supplier reviews, and maintain supplier documentation within the QMS, ensuring ongoing compliance and accuracy of records
• Maintain back-ups of QMS and supplier documentation in Share Point in alignment with Medichecks e QMS (Master Control).
• Assist the Senior QARA manager in the monitoring and mitigation of QMS related business risks
• Carry out administrative activities within the e QMS to support audit preparation, reporting, and close-out of findings.
• Develop and maintain Quality & Regulatory (QARA) department FAQs, ensuring they remain accurate and accessible.
• Communicate with key stakeholders to ensure departmental adherence to relevant SOPs.
• Identify opportunities to improve or streamline QMS processes and elevate proposals to the Senior Quality & Regulatory Manager.

Skills and Experience

• 2 years of experience within the Medical Device & IVD industry.
• Good working knowledge of industry standards and regulations ISO 13485, IVDR, UK MDR.
• Experience working to an established QMS.
• Direct experience of CAPA and non-conformance logging and trending.
• Prioritisation of workload and well organised with task management.
• Good communication skills interacting with stakeholders at all levels.
• Confident presentation skills to present to stakeholders when required.
• Confidently use Excel/reporting tools available to you to create summary reports of key KPI’s and quality objectives within the business
• A supportive team player who’s happy to step in, try new things, and ask for help when needed.
• Experience working with an e QMS system. (e. g. Mastercontrol, Q-Pulse)
• Internal Auditor experience and/or qualification.
• Experience in maintaining and collating critical supplier documentation.
• How we work

We have adopted a flexible hybrid approach to working in both the office and at home, having seen the benefits of both for everyone during the last year.

You will predominantly work from home, but sometimes we will get together to collaborate, or for 121s.

We offer flexible working around our core business hours and trust you to work enough hours to do your job well, at times that suit you and your team.

Medichecks people, perks and culture

We are committed to making Medichecks a great place to work and have shaped our people strategy around our colleagues’ feedback and we are continuously reviewing this.

As well as a competitive salary and the chance to make a real impact in an organisation, here's a taste of some of the things we offer.

• 25 days of glorious holidays, plus all of the bank holidays.
• The option to buy and sell holiday.
• Hybrid working- working anywhere from the UK.
• Flexi lunch breaks – grab lunch with a friend or hit the gym.
• Enhanced maternity and paternity leave, as part of our family friendly policies.
• Enhanced paid sickness leave.
• Free and discounted Medichecks blood tests for you and your family and friends.
• Free access to an online GP service.
• Free eye tests and flu jabs.
• Access to discounts and freebies through our reward platform.
• 2 days of paid leave to give some of your time to a charity or community of your choice.
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