Senior Design History File lead - Full-time / Part-time

Facilitate creation of retrospective Design History Files for several drug/device combination products from an initial indexing of historical documents through to completion. Use historical documents in hard copy and electronic formats to retrospectively construct the design and development history of multiple drug/device combination products in accordance with company document & design control SOPs and FDA regulations. Compile work done by the team, ensure effective risk management, and conduct gap analyses and support efforts to fill identified gaps. This position requires a sustained high level of attention to detail and the ability to review and read documents for the majority of the day.

Work with project managers and technical leads to initiate and maintain Design History Files per CFR 820.30 throughout the design process.

Support development of an implementation strategy to retrospectively create/update design history files for combination products.

Create flowcharts, explanatory documents, and project plans.

Understand and apply design control SOPs, FDA Guidance, and regulations FDA 21 CFR 820.30 & FDA 21 CFR Part 4.

Understand, categorize, and summarize a variety of documents, such as engineering drawings, test reports, manufacturing reports, memos, correspondences, purchase orders, and meeting notes.

Reconcile and harmonize work across the project team. Responsible for leading and documenting gap analyses and creating reports for DHF. Work with project teams, vendors and suppliers and perform risk management to facilitate gap analysis.

Ensure effective risk management activities at external design companies and all manufacturing facilities related to assigned projects Provide input and support to human factors usability studies for assigned projects Identify gaps in design history file in accordance to company standards and regulatory requirements and work to find methods of closing the gaps.

Work with project teams, vendors and suppliers, and use primary historical documents to write combination product design control documentation.

Work with regulatory to provide all required documentation for regulatory submissions for assigned projects

Responsible for generation and storage of all design control documentation for assigned projects

Responsible for generation, approval and storage of all human factors engineering documentation for assigned projects

Responsible for generation, approval and storage of all manufacturing control strategy documentation for assigned projects

Participate in the day-to-day activities of the team, including active participation in the indexing of historical documents.

About Aerotek:

Our people are everything. As a Best of Staffing® Client and Talent leader, Aerotek® Inc. has distinguished itself as a leader in recruiting and staffing services, by having a deep understanding of the intersection of talent and business. As a strategic partner to more than 17,000 clients and 300,000 contract employees every year, Aerotek's people-focused approach yields competitive advantages for its clients and rewarding careers for its contract employees. Headquartered in Hanover, Md., Aerotek operates a network of over 230 non-franchised offices with more than 6,000 internal employees dedicated to serving our customers. Aerotek is an operating company of Allegis Group, a global talent solutions provider. To learn more, visit .

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