Temporary, Full-time Remote Position 

9 months - 1 year

Summary of Position:

The Quality Design Assurance Specialist will perform detailed review, remediation, and creation of Design History Files (DHFs) to ensure compliance with FDA, ISO 13485, and internal design control requirements. This role is hands-on and execution-focused, responsible for completing structured gap assessments, and generating compliant design control records for both legacy and current products.

Essential Functions, included but not limited to:  

• 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.

Supervisory Responsibilities:

• None.

Travel:

• 5%; possible travel to Boerne, TX

Required Qualifications:

• 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 Qualifications:

• Familiarity with products similar to EKFs.
• Experience with legacy product remediation.
• Knowledge of IEC 62366 and IEC 61010.

Basic Skills and Abilities:

• Project a positive company image by interacting with fellow employees, customers, and management in a cooperative, supportive, and courteous manner; displays a professional attitude.
• Good computer skills including Microsoft Word, Excel, Outlook.
• Detail oriented with a high level of accuracy, efficiency, and accountability.
• Excellent organizational skills to meet goals and set priorities.
• Proven ability to handle multiple priorities and meet deadlines; work in a fast-paced environment.
• Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
• Ability to work independently and as a member of various teams and committees.