Full-Time
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EKF Diagnostics
51-200 employees
Produces point-of-care diagnostics and related biotech
No salary listed
Shavano Park, TX, USA
In Person
 QA & Testing (1) |
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- Bachelor's degree (B.A./B.S.) from an accredited college or university in a science related field
- Legally authorized to work in the United States
- Five (5) years quality assurance experience
- Two (2) years quality experience in relation to medical device or In vitro diagnostics devices
- Two (2) years of supervisory experience
- Strong knowledge of various standards and regulations such as ISO 9001, ISO 13485, ISO 14971, the Quality System Regulation (21 CFR Part 820), Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch3), the Brazilian Good Manufacturing Practices (RDC ANVISA 665/2022), the Canadian Medical Devices Regulations, and any specific requirements of the medical device regulatory authorities participating in the MDSAP program
- Appointed as the local Management Representative
- Direct activities of the quality system to ensure compliance to both national and international requirements
- Support the administration of the Supplier Quality Management process. Manage the Supplier program to include the selection, evaluation, and ultimate approval of new suppliers. Monitor the performance of suppliers
- Conduct training in current Good Manufacturing Practice (cGMP), International Organization for Standardization (ISO) standards
- Regulate document control systems including labels, IFU revisions, operating procedures, etc., and all related documents that create the Quality Management System, meeting ISO, GMP/QSR, and company directives
- Write and update standard operating procedures (SOPs)
- Oversee of the upkeep of the training program database. Conduct the annual review of the Quality System and cGMP training
- Monitor the customer complaint handling process through review and approval of completed complaint investigations
- Coordinate Corrective and Preventative Actions (CAPAs) and non-conformance activities
- Review and release finished goods; may review and release in-process goods (IPG) in the absence of the Quality Control Manager
- Review stability test results
- Create and maintain the annual internal audit schedule. Ensure internal auditors are trained
- Coordinate and serve as point of contact for audits conducted by registrars, certifying bodies, and customers to include end-users, distributors, and other OEM customers, as applicable
- Support audits conducted by regulatory agencies
- Develop and maintain performance of site Quality Assurance staff utilizing common practices, quality methodologies, processes, and tools to ensure consistent and effective quality product outcomes
- Lead, maintain, and improve the QMS in line with ISO 9001, ISO 13485 and MDSAP, to ensure all aspects of the QMS are understood, implemented, and maintained by staff
- Establish and maintain key performance indicators (KPIs) to gauge overall effectiveness and business impacts of the organization
- Ensure Management Review of the QMS is completed and documented to reflect the status of the QMS effectiveness and resulting improvements
- Provide leadership and mentorship in non-conformance management and CAPA processes, by ensuring quality investigations are robust, timely and conducted and documented in accordance with company requirements
- Implement effect validation strategies in support of continuous improvement with established and evolving regulatory and company requirements
- Identify and implement continuous improvement strategies on multiple axes, including but not limited to process, tools, methodologies, and functional competencies
- Interact with all company personnel in coordination of quality and regulatory activities and sound business practices in compliance with Quality Policy and Directives
- Adhere to current Good Manufacturing Practices(cGMP); Ensure all direct reports comply
- Comply with Company policies, Quality Management System (QMS) and Standard Operation Procedure (SOPs), etc.
- Five (5) years proven quality experience in relation to In vitro diagnostics devices
- Knowledgeable with ERP systems such as ProAlpha, Oracle, SAP and AS400
- Prior manufacturing experience
EKF Diagnostics develops, manufactures, and distributes diagnostic technologies and life-science materials for point-of-care testing, diabetes care, hematology, and biotech applications. Its products include near-patient in-vitro diagnostics devices, glucose monitoring systems, and hematology tools, plus enzymes, reagents, and beta-hydroxybutyrate products for research and pharma production, along with precision fermentation and contract manufacturing services. These products are designed to be used at or near the patient and, in some cases, coupled with data connectivity software to deliver quick, actionable results for clinicians and researchers. EKF aims to improve health outcomes by providing reliable diagnostics and biotech solutions that empower clinicians, scientists, and researchers to make informed decisions.
Company Size
51-200
Company Stage
IPO
Headquarters
Penarth, United Kingdom
Founded
1990
Simplify's Take
What believers are saying
- Blood Centers of America hematology deal expands US market presence for hemoglobin analyzers.
- €4.65m African and Latin American hematology contracts drive production capacity expansion.
- Beep Insights acquisition adds real-time glucose and lactate tracking with Bluetooth wearable integration.
What critics are saying
- HemoCue 301 and Hemo Control outperform DiaSpect in AABB 2025 benchmark study accuracy.
- Abbott's i-STAT dominates POC glucose/lactate testing with broader menu and superior IT integration.
- Roche's cobas pulse AI-driven connectivity surpasses EKF Link, locking EKF out of hospital contracts.
What makes EKF Diagnostics unique
- Rapid point-of-care hemoglobin analyzers (DiaSpect, Hemo Control) enable decentralized donor screening.
- EKF Link software platform integrates POC devices with hospital and laboratory IT systems.
- Diversified product portfolio spans glucose, lactate, hematology across veterinary, sports, and clinical settings.
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Benefits
Health Insurance
Paid Sick Leave
Professional Development Budget
Company News
Connect with EKF at AABB 2025 in San Diego, USA. EKF Diagnostics will be exhibiting at the AABB Annual Meeting 2025, taking place 25 - 28 October 2025 at the San Diego Convention Center, San Diego, CA, USA. EKF delivers diagnostic technologies and biotechnology solutions, empowering healthcare and medical providers to make informed clinical decisions through point-of-care testing and life sciences applications. EKF Diagnostics is delighted to announce that EKF will be presenting new data at AABB 2025. Join EKF Diagnostics in the Poster Hall (SDCC Exhibit Hall F-H, AABB Learning Theater) to view: In this study, EKF Diagnostics benchmark the DiaSpect Tm hemoglobin analyzer against HemoCue 301, Hemo Control, and ABL90 Flex - all using venous whole blood. The results show excellent agreement, clinically acceptable biases, and underline DiaSpect Tm's key benefits: rapid results, portability, and ease of use. These attributes make it an excellent option for mobile and decentralized donor screening. You can also visit EKF at Booth #1210 to explore its latest diagnostic solutions that support accurate, reliable, and efficient testing. Some of its featured solutions include: * Hemo Control - A hemoglobin and hematocrit analyzer designed to provide quick lab-quality results from one simple test, enhancing patient care in blood banks, hospitals, and medical offices. * DiaSpect Tm - A hand-held hemoglobin analyzer delivering immediate lab-quality results in just one second, making it a valuable tool for screening and testing, essential for remote or mobile settings. * EKF Link - Explore EKF Link, its versatile software platform that connects point-of-care devices seamlessly to hospital and laboratory IT systems. The 2025 AABB Annual Meeting brings together the latest research and practice-changing resources for the fields of blood and biotherapies. Colleagues from throughout the world attend to connect, network, learn and advance the field. Don't hesitate to contact your EKF Sales representative or email [email protected] to arrange a dedicated meeting. EKF leads the way with cutting-edge point-of-care diagnostic solutions that empower healthcare professionals and patients with rapid, accurate, accessible testing capabilities and results. Its technologies enable informed decision-making, timely interventions, and improved patient outcomes at the point-of-care. EKF Diagnostics look forward to welcoming you to AABB 2025 and exploring how EKF's diagnostic solutions can support your healthcare needs. For specific event enquiries please contact [email protected]. For all other product enquiries, sales enquiries, technical support enquiries or anything else regarding its Point-of-Care, Life Sciences, or Central Laboratory products and services please visit its contact page.
EKF Diagnostics Holdings, the AIM-listed global diagnostics business, has announced the launch of its new Biosen C-Line (Biosen), an advanced version of its industry leading rapid benchtop glucose and lactate analyser.
In October 2022, EKF launched a new version of DiaSpect Tm, now powered by EKF Link, enabling new functions like Hematocrit calculation, quality control management and patient data management functions.
For instance, in July 2020, EKF Diagnostics, a UK-based medical diagnostic and healthcare company, launched the PrimeStore MTM, a novel molecular transport media for simultaneous COVID-19 and influenza sampling.
For instance, in December 2022, EKF Diagnostics, a UK-based vitro diagnostics company, launched a new version of the Lactate Scout analyzer for veterinary applications.