Round lake Round lake, IL 60073
Job Title: Project Engineer
Location: Round lake, IL - 60073
Duration: 6+ Months Contract
About our Client : Our Client is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions – underpinned by the world’s largest delivery network – Our Client works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With approximately 425,000 people serving clients in more than 120 countries, Our Client drives innovation to improve the way the world works and lives
- Good understanding of product lifecycle, BOM structuring, standardization, Change management process.
- Review the Labeling Gap Assessment for regulatory compliance and provide review comments to Gap Assessors.
- Prepare or compile the Regulatory documents according to Regulatory requirements.
- Review and Approve Labeling Contents, SOP’s & Other related documents.
- Co-ordinate and Guide the Offshore team members for the Complex Queries.
- Respond to QA / RA team’s Questions.
- Responsible for managing the development and release of all Product Labelling deliverables.
- Responsible for maintaining excellent collaborative relationships with R&D, Product Marketing, Regulatory/Quality and other business functions.
- Develop project Plans to meet the Regulatory and Business Unit’s deadlines.
- Experience in PLM tools – ERP, Teamcenter, SAP and any other PLM Tools.
- Excellent skills in MS Office (Word, Excel & PowerPoint) and MS Access tool.
- Highly proficient in configuration management.
- Maintain and own internal documents.
- Write, revise and review SOP's
- Experience in CAD drawings (ProE/AutoCAD) & Product specifications.
- Change control processes.
- Data/Document configuration management proficiency.
- Strong project management skills.
- Exceptional organizational skills and ability to plan and implement resolutions to technical problems.
- Familiarity with interpreting regulations and quality systems.
- Understand strategies and be able to develop new businesses process/tools.
- Good interpersonal/communication /influencing/negation skills.
- Good project management skills
Technical / Soft Skills:
- Exposure to Good Documentation Procedures.
- Medical device experience
- Experience in Medical Products Labeling Process.
- Knowledge on UDI & GUDID
- Change Control Management
- Configuration Management
- Oral and Written Communication
- Experience leading cross-functional teams.
- Knowledge of product/document configuration management.
- Working knowledge of related business systems.
- Experience with Product Data Management/documentation systems, or equivalent change control system.
- Technical / Soft Skills
- Cross functional liaison
- Good interpersonal skills,
- Good communication, writing and documentation skills
- Bachelor’s degree or country equivalent in related scientific discipline with a minimum of 5 years of regulatory experience in RA or related field, including managing people or projects.
About ASK: ASK Staffing is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Staffing connects people with amazing opportunities.
Jeff Kasula @ email@example.com - 415-200-4127