Quality Manager needed in Kimbolton, Cambridgeshire, United Kingdom

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Quality Manager

Company: WORKHUB AGENCY

Job Location: Kimbolton, Cambridgeshire, United Kingdom

Job Type: FULL_TIME - (ON_SITE)

Job Salary: 0 USD per month.

Date Posted: April 06, 2025

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Job Description

ActivInsights is a digital health company that specialises in the objective measurement of physical behaviours and lifestyle. Our technologies are used worldwide within the clinical trials, health management, and research markets to provide accurate and continuous monitoring of lifestyle outside of the clinic environment. We develop novel health measures from data collected by our own professional wearables and other connected devices such as phone apps within a scalable global and secure infrastructure. Advanced data analytics reveal insights that support pharmaceutical drug development, clinical practice, and disease management. https://www.ActivInsights.com/ We are looking for a Quality Manager to work within the Activinsights team to manage the business's quality function and ensure quality, compliance & customer requirements are met. The successful candidate will be responsible for ensuring all our products, services, and internal functions are compliant with required standards. This full-time post is based at our offices in Kimbolton.This is a key role that supports the global delivery of Activinsights’ medical device wearables and services within the clinical, healthcare, and academic markets. We are a growing team with a fully cloud-based IT infrastructure and minimal legacy systems. The role is central to the progression of the company into the clinical trials market and will support the global commercialisation of innovative products and services.ResponsibilitiesSupporting the transition and ongoing development of the company’s eQMS Management of the company's quality management system Management and facilitation of CAPA and audit findings - ensuring compliance to international regulations and internal requirementsAccountability for all quality requirements for the business Accountability for monitoring and maintenance of existing processes Hosting external audits and performing internal auditsEnsuring compliance for all existing and new products and servicesIdentifying, collecting, and analysing monthly performance and quality metrics (KPIs) and other QMS performance data using appropriate methodologies and toolsInvestigating quality problems, determining root causes, gathering and analysing dataImplementing corrective action to reduce or eliminate causes, to provide trending analysis on quality issues and performance metricsEnsuring consistent documents and records controls are executedEnsuring cGMP are performed throughout the business· Other duties and general office activities within a small, growing, and friendly teamYou will work with:• the Regulatory Affairs Manager to define, manage, and ensure implementation of all elements of the quality management and quality assurance strategy• customers to support vendor audits, answer queries, demonstrate compliance, and manage complaints• regulatory authorities to face audits and manage the implementation of audit findings• suppliers to ensure compliance and manage non-conformities• the operational team to ensure that all aspects of the QMS are understood, implemented, and maintained• the development team to support the creation of verified and validated new products and services. Candidate AttributesEducated to graduate level or equivalent, you will be a methodical thinker, capable of making rational judgments from available information and meeting targets in agreed time scales. You will have good written English skills and be able to lead the quality function within the wider team. You must have a proven ability to work autonomously, driving innovation where possible.In your career so far, you will have had significant experience of medical device quality management with excellent knowledge of ISO13485 and 21 CFR 820. You will be confident working in quality assurance within a regulated environment.Substantial experience in the electronics or medical devices industry is required and experience working with engineered devices and data management (ISO27001) would be advantageous. Pension Scheme: The company pays 5% of salary into a scheme with employee contributionsAdditional Benefits: Employee share options scheme. Private Medical and Dental Care, group life cover.

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