A fast-growing medical device company in the northern Twin Cities metro has an immediate opening on their team for a contract to hire Technical Coordinator! If you desire to step into the medical device world, this is the opportunity for you!
Create, Review, Track ECOs for R&D Audit/Maintain/Provide secure access to DHF Maintain IBM Rational DOORS documents. Coordinate updates to department documents. Process Improvement Initiatives Conduct product release paperwork activities (PLR, NFG)R&D coordinator for industry standards and Standards Assessment Checklist (SAC) process Perform tasks as assigned to support R&D Department technical activities Create, Review, Track ECOs for R&D. Work with appropriate functions to create/update ECO documents. Ensure documents are in the proper format. Route critical documents for signatures. Audit/Maintain/Provide secure access to DHF. Place documents in DHF / Provide a point person for secure DHF access. Audit DHF throughout project for missing documents. Write memos and meeting minutes for DHF as required. Maintain IBM Rational DOORS documents. Import/Export documents to and from DOORS. Create/Maintain DOORs templates. Keep DOORS documents up to date. Perform requirements traceability using DOORS. Coordinate updates to department documents. Work with appropriate functions to update FMEA, Standard Checklists, Product Specifications, Media Specs, Hazard Analysis documents and other department documents as necessary. Process Improvement Initiatives. Supports manager and department in process improvement initiatives. Creates consistency in document formats and templates. Conduct product release paperwork activities (PLR, NFG). Organize R&D input to PLR forms, research and enter required information into form for product release. Assist PM with NFG form, gain signatures on form. R&D coordinator for industry standards and Standards Assessment Checklist (SAC) process. Keep standards library up to date with new standards required by projects. Update SAC SOP documents as standards change and new revisions are released. Perform tasks as assigned to support R&D Department technical activities. Coordinate Part numbers, 21 level part releases, Article Quality Assessments, Label releases, Aspect/Impact. Provides guidance and support to internal customers. Work with internal customers to address document related issues and set priorities. Supports Manager. Support manager by implementing assigned tasks within the department. Work on special projects assigned by Manager. Provide on-going training to Smiths Medical employees pertaining to Document Control procedures. This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site). Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement. Other duties as assigned by supervisor.
• AA or Trade Degree, or exhibited experience through past work history required, Bachelor’s degree preferred.
• Prefer minimum 3 years of experience in a Medical Device organization
• Prefer experience to be applicable to standard Document and Data control activities in a Quality System regulated environment.
• Knowledge of and ability to use personal computers to operate company systems e.g. Oracle, SharePoint, MS Word, Excel, Access, Project, Adobe Acrobat, IBM Rational DOORS, etc.
• Oracle experience desired
• IBM Rational DOORS experience desired
• Knowledge of IEC 60601-1 series of medical device standards desired Abilities
• Ability to rapidly master internal procedures and methods such as Documentation System, ECOs, DVTs, etc. Impact and Scope
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