Kingham Quality Assurance & Control Job Listings

Test Manager, Digital Health & IoT (IEC 62304, ISO 13485)63845426718723120

Workable

Test Manager, Digital Health & IoT (IEC 62304, ISO 13485)

Albus Health is a nocturnal biomarker company spun out of University of Oxford. We have developed Albus Home, a contactless multisensory platform that monitors a wide range of nocturnal parameters without the patients having to do or wear anything. The product incorporates state of the art sensor technology, with sophisticated machine learning and signal processing algorithms, collecting continuous, objective and accurate physiological data from the patient’s home. Albus Home is certified for use in 25 countries, and has been used to collect over 5 billion data points across a dozen physiological and environmental parameters. Our clients include some of the world’s largest pharmaceutical companies, and partners include some of the most reputed opinion leaders in respiratory medicine and beyond. Our team members have built unicorns in healthtech/biotech and are global leaders in medicine, drug development and healthcare technology. Albus Health is at an exciting growth stage at which we need to scale fast deliver to new contracts within ambitious timelines and grow to meet the industry demands for our products and services. We are seeking an experienced and highly motivated Test Manager to lead our testing efforts for a critical software product under development. You will be instrumental in defining, implementing, and overseeing comprehensive testing strategies and processes throughout the software development lifecycle. This is a key role for a self-starter who thrives in a regulated environment and can expertly navigate software validation. Key Responsibilities Test Strategy & Leadership: Lead and manage the entire testing lifecycle, defining and implementing comprehensive test strategies, plans, and protocols that align with business requirements and regulatory standards. Compliance & Validation: Drive software validation and ensure adherence to relevant medical device regulations, including IEC 62304 for software lifecycle processes, ISO 14971 for risk management, and ISO 13485 for quality management. Oversee the creation and review of all necessary GxP-critical validation documentation. Test Execution & Reporting: Manage the execution of all testing phases and the defect lifecycle. Provide clear and concise reporting to stakeholders on testing progress, risks, and product quality. Process Improvement: Continuously evaluate and improve testing methodologies, tools, and processes to enhance efficiency and maintain compliance with evolving industry best practices and standards. Requirements Bachelor's degree in Computer Science, Software Engineering, or a related technical field. Minimum of 3 years of experience in software quality assurance and testing, with significant experience in regulated environments. Demonstrated expertise in software lifecycle processes (IEC 62304), risk management (ISO 14971), and quality management systems (ISO 13485). Strong understanding of relevant regulations such as FDA 21 CFR Part 11 and EU Annex 11. Proven experience in developing and implementing robust test strategies, plans, and cases. Proficiency with test management tools (e.g., Xray), defect tracking systems (Jira), and collaboration tools (Confluence). Excellent communication and interpersonal skills, with the ability to lead a team and work with stakeholders. Strong analytical and problem-solving abilities with meticulous attention to detail. A self-starter with the ability to manage your own workload effectively within an agile team. Desirable Skills Expertise with GxP and GAMP5 guidelines and their application to software development and validation is useful but not essential. Relevant certifications (e.g., ISTQB, CSQE). Experience with automated testing frameworks and tools. Familiarity with Agile/Scrum development methodologies. Exposure to Electronic QMS (Quality Management System) systems such as Ketryx, Cognidox, or similar would be a distinct advantage. Understanding of the various technologies involved in an Internet of Things and machine learning product: Cloud software (AWS), Embedded software and electronic devices. Benefits Competitive salary based on experience and qualifications. Preference for on-site collaboration with option for some hybrid work

Oxford, UK

Negotiable Salary

Workable

Quality Assurance Lead

Albus Health is a nocturnal biomarker company spun out of University of Oxford. We have developed Albus Home, a contactless multisensory platform that monitors a wide range of nocturnal parameters without the patients having to do or wear anything. The product incorporates state of the art sensor technology, with sophisticated machine learning and signal processing algorithms, collecting continuous, objective and accurate physiological data from the patient’s home. Albus Home is certified for use in 25 countries, and has been used to collect over 5 billion data points across a dozen physiological and environmental parameters. Our clients include some of the world’s largest pharmaceutical companies, and partners include some of the most reputed opinion leaders in respiratory medicine and beyond. Our team members have built unicorns in healthtech/biotech and are global leaders in medicine, drug development and healthcare technology. Albus Health is at an exciting growth stage at which we need to scale fast deliver to new contracts within ambitious timelines and grow to meet the industry demands for our products and services. We are seeking a proactive and highly organised Quality Assurance Lead to join our growing team. The Quality Assurance Lead is responsible for leading the quality and compliance function within Albus Health and managing the regulatory risks of the business. The QA Lead leads the quality and compliance team and is the quality management spokesperson for the company on both strategic and tactical matters relating to the quality management. This is a full-time on-site position based in Albus office premises in Oxford. We will consider 4 days/week and partially remote arrangements for the right candidate. Requirements Key Responsibilities Lead the quality and compliance functions of the organisation Manage and own the quality management system Supports development of organisational strategies within the company by aligning quality and compliance to the strategic thinking and the direction of the company Sign off on deliverables as per the approval matrix Support and guide the team in ongoing development, CAPA/NC activities, tracking training, RFx responses and other continuous improvement activities Act as the Management Representative and be responsible for Management Review meetings Skills Experienced professional with a significant understanding of how to transform key quality management functions and processes. Strategic and analytical with demonstratable experience in improving quality management disciplines, systems and processes, including KPIs - both within the quality and compliance areas and across the business Experience of working in both product and services led environments Experienced in building and maintaining relationships with key stakeholders Strong experience of quality and compliance management in life sciences domain; should have worked hands in in medical devices and CSV/GAMP5 Subject matter expertise on GCP and information security and operational experience in life sciences industry Ability to support strategic discussion with the CEO, challenge and influence the business leadership to facilitate sustainable growth Experience A successful track record as a QA Lead with full responsibility in a business of comparable scale and complexity to Albus Health Strong knowledge of regulatory framework and compliance requirements applicable to vendors supplying to pharmaceutical clinical trials and medical devices including information security standards Experience in the technology enabled services/software/business processing outsourcing/information services sector and/or adjacent sectors Demonstrable experience in taking a company to the next level of performance through maximising quality, product and service delivery 6-8 years experience of operating in a regulated environment - Medical Devices and CSV/CSA/GAMP5 Experience in enhancing quality management process and business controls and of upgrading a quality and compliance function, including systems and processes Experience in leading change in a structures and sensitive manner and the ability to help prepare and adapt others to change in business and customers needs About You High calibre leader who motivates and inspires other to achieve organisational objectives on quality and compliance Ability to communicate effectively and clearly with the business, internal and external stakeholders and help the quality function become a valued part of the business Ability to lad teams as well as function independently on quality related projects A proactive self-starter with and entrepreneurial mindset who understands the Albus Health business model and strategic plans. Pragmatic and willing to 'roll up their sleeves' An appreciation for the change management necessary for the business and the ability to articulate that change in a structured manner A natural communicator who maintains a regular dialogue with key stakeholders Engaging with employees at all levels enabling them to understand the critical quality factors at their own level of understanding Strong leadership shills - ability to develop, manage and run a team and work closely with managers

Oxford, UK

Negotiable Salary

Workable

Quality Inspector

We are currently seeking an Quality Inspection Technician to join a well-established, leading manufacturing business based in Gloucester. The Quality Inspection Specialist plays a crucial role in ensuring the quality of incoming and outgoing goods in a manufacturing setting. From meticulous inspections of materials and finished products to collaborating with cross-functional teams and suppliers, the role involves maintaining compliance with quality standards and driving continuous improvement. If you are a seasoned professional with a passion for quality, this is the role for you Responsibilities Conduct meticulous inspections of incoming raw materials, components, and finished goods to ensure compliance with quality standards. Perform detailed examinations during outbound processes to verify adherence to quality requirements and packaging standards. Collaborate closely with production teams to identify and address quality issues in real-time, ensuring timely resolutions. Maintain accurate records of inspection results and report any non-conformities to relevant stakeholders. Implement and enforce quality control procedures, conducting regular audits to ensure adherence to standards. Collaborate with suppliers to address quality concerns and actively participate in implementing corrective actions. Work closely with cross-functional teams to enhance overall product quality and customer satisfaction. Participate in the development and continuous improvement of quality control processes and procedures Requirements Bachelor's degree in Quality Management, Industrial Engineering, or equivalent practical experience. Previous experience in a quality inspection role within a manufacturing environment. In-depth knowledge of quality control principles, methods, and techniques. Detailed knowledge of ISO 9001 requirements is highly beneficial. Strong analytical and problem-solving skills. Excellent communication skills, both verbal and written. Proven experience in conducting root cause analysis and implementing corrective and preventive actions. Detail-oriented with a high level of accuracy in inspection and documentation. Ability to work independently and collaboratively in a fast-paced environment Benefits Salary- £35-000- £45,000 DOE Bonus Hours- 7.30am-4.30pm

Gloucester, UK

£35,000-45,000/year