EKF Diagnostics · 6 hours ago
Quality Design Assurance Specialist
United States
Full-time
Onsite
Mid Level
4+ years expEKF Diagnostics is seeking a Quality Design Assurance Specialist to ensure compliance with FDA and ISO standards through detailed reviews and creation of Design History Files. The role involves executing gap assessments, collaborating with various teams, and maintaining compliant documentation throughout the product lifecycle.
Health CareHealth DiagnosticsManufacturing
Responsibilities
Perform comprehensive reviews of existing DHFs
Identify gaps, inconsistencies, and missing documentation relative to ISO 13485:2016, 21 CFR 820, and other applicable requirements, as well as EKF procedures
Execute remediation activities to bring DHFs into full compliance
Reconstruct or create design documentation as needed, including: User Needs & Design Inputs, Design Outputs, Verification & Validation protocols and reports, Risk Management Files (ISO 14971), Design Review documentation, Traceability Matrices
Conduct structured gap assessments and document findings with clear traceability
Collaborate with Quality, Manufacturing, Procurement, and Regulatory teams to gather required information and close gaps
Ensure all documentation is inspection‑ready and aligned with current regulatory expectations
Create new DHFs or major DHF sections for products lacking complete design documentation
Support design control activities for product changes, sustaining work, and new product introductions
Maintain clear, compliant documentation aligned with EKF’s QMS
Support the integration of risk controls into, design activities and other workflows to ensure that identified risks are effectively mitigated, implemented, and maintained throughout the product lifecycle
Support updates to design‑related standard operating procedures (SOPs) to ensure the design process fully covers User Needs through Design Inputs, Outputs, Verification, Validation, and Design Transfer. Ensure that changes are assessed bidirectionally, from production back into design and from design into production, with clear linkages, traceability, and documented rationale throughout the process
Ensure all work complies with ISO 13485, ISO 14971, FDA QMSR, and other applicable requirements, as well as EKF internal procedures
Apply design control best practices to ensure documentation integrity and traceability
Support internal training on design control requirements and best practices, ensuring clear knowledge transfer and consistent understanding across cross‑functional teams
Adhere to current Good Manufacturing Practices(cGMP)
Comply with Company policies, Quality Management System (QMS) and Standard Operation Procedure (SOPs), etc
Qualification
Required
Legally authorized to work in the United States
Bachelor's degree (B.A. /B.S.) from an accredited college or university in a technical, scientific, or related field
Four (4) years of experience in medical device design controls or design assurance
Experience with IVD products, reagents, or diagnostic instrumentation
Strong design control knowledge with demonstrated experience reviewing, remediating, or creating DHFs
Strong knowledge of various standards and regulations such as ISO 9001, ISO 13485:2016, ISO 14971, the Quality System Regulation (21 CFR Part 820)
Ability to interpret and apply regulatory requirements
Proven ability to translate complex technical concepts into clear, concise, and user-friendly documentation for both technical and non-technical audiences
Strong analytical mindset with a track record of identifying trends and translating findings into comprehensive reports, process maps, and standard operating procedures (SOPs)
Demonstrated expertise in rigorous root-cause analysis and the production of high-quality technical documentation, ensuring accuracy and knowledge retention across the organization
Preferred
Familiarity with products similar to EKFs
Experience with legacy product remediation
Knowledge of IEC 62366 and IEC 61010
Company
EKF Diagnostics
EKF Diagnostics manufactures point of care equipment for measuring glucose, lactate, hemoglobin, hematocrit, and glycated hemoglobin
201-500 employees
Funding
Current Stage
Public CompanyTotal Funding
unknown2010-07-07IPO
2010-06-01Series Unknown
Leadership Team
Stephen Young
Chief Financial Officer
Sergio Daniel Stilman
LATAM Sales Director
Recent News
2025-12-18
EIN Presswire
2025-11-14
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