- Abbott (Westfield, IN)
- …Our 114,000 colleagues serve people in more than 160 countries. ** Quality System & Regulatory Compliance Manager** **Working at Abbott** At Abbott, ... leadership in quality and regulatory compliance matters. The Quality System ...Manage all phases of external audits. + Serve as Quality Systems Subject Matter Expert and Generalist/Escort.… more
- Cardinal Health (Indianapolis, IN)
- …clinical operations, project management, medical affairs, legal, medical writing, nonclinical, and quality teams to ensure regulatory compliance in clinical ... in accordance with regulatory agency requirements and internal standards. + ** Regulatory Compliance ** + Ensure ongoing compliance with applicable… more
- Insight Global (Lebanon, IN)
- …quality management software and tools. - Detail-oriented with a strong commitment to quality , safety, and regulatory compliance . - Ability to work ... Job Description Insight Global is seeking a quality manager for one of our aerospace clients...overall company policy development to ensure safety, efficiency, and regulatory compliance within the aviation industry. The… more
- Takeda Pharmaceuticals (Indianapolis, IN)
- …for the strategic and operational activities pertaining to global and local labeling compliance and quality within Global Regulatory Affairs. + Partners ... compliance and labeling processes (labeling event management systems , RIM systems , and quality ...with good exposure to Regulatory Affairs, labeling, quality assurance, and/or compliance . + Familiarity with… more
- Cook Medical (Bloomington, IN)
- …acknowledgements, etc. in a timely manner. Within scope of responsibility, ensure all quality , regulatory , compliance and product specific requirements are ... the Division, Marketing, company Functions, and Operational Units (including R&D, Regulatory Affairs, Quality Assurance, Quality Engineering, Engineering,… more
- Merck (Indianapolis, IN)
- …working with device component and sub-assembly suppliers. + Strong knowledge of global quality system and regulatory requirements for combination products, ... drug delivery systems . + Ensure adherence to quality standards and regulatory requirements throughout the...continuous improvement strategies for device quality and regulatory processes. + Monitor and ensure compliance … more
- Fresenius Medical Center (Indianapolis, IN)
- …ensuring appropriate actions taken to ensure required resolution. Demonstrates pride in the quality of work, regulatory compliance , and the environmental ... vision, core values and customer service philosophy. Adheres to the FMCNA Compliance Program, including following all regulatory and FMS policy requirements.… more
- L3Harris (Fort Wayne, IN)
- …of the following: Supply Chain, Subcontracts, Contracts, Procurement, Program Management, Engineering, Quality , Regulatory Compliance , Legal and Government ... in terms of supplier risk, financial stability, technical capability and quality management system assessments. Subcontracts support government, customer and… more
- Lilly (Indianapolis, IN)
- …working on long-term technology solutions, leading and supporting efforts to drive optimization, regulatory and Quality compliance , and reliability of unit ... to drive understanding and knowledge of large scale SDD systems . + Collaborate with manufacturing sites to solve current...the development and use of control strategies, unit operations, Quality and regulatory compliance and… more
- Fujifilm (Indianapolis, IN)
- …on schedule. + Completion of provided trainings. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures ... similar resources on existing products. + Learn and remain compliant with all regulatory and quality requirements. + Occasionally participates in customer site… more
- Walmart (Fort Wayne, IN)
- … Systems (for example, CAPA, Non-Conformance, Trending, Customer Complaints, System /Process Change Control, etc ) compliance and drives improvements by ... for families. We are seeking to hire an experienced Quality Systems Specialist within our food manufacturing... and/or regulatory objectives for increased efficiencies, compliance , and quality relating to the business… more
- Dairy Farmers of America (Richmond, IN)
- …department and ensure effective quality execution, continuous improvement, and regulatory compliance . In conjunction with plant operations, maintain an ... concerning food safety, Food Safety Modernization Act (FSMA), and regulatory compliance + Provide quality ...samples; generate Certificate of Analysis (COA's) + Maintain the quality management system and ensure documents are… more
- Zimmer Biomet (Warsaw, IN)
- …comprehension of digital information/data to incorporate into process improvement, maintenance, quality , regulatory compliance , and validation disciplines. ... a subject matter expert to implement and support advanced manufacturing technology, processes & systems in operations. **This position is on site 5 days per week in… more
- Tecomet (Warsaw, IN)
- … requirements, create, monitor and improve quality systems /programs, reduce quality costs and maintain compliance within FDA and ISO regulations for + ... Regulatory Manager will provide overall company leadership and direction for Quality Assurance and Regulatory Affairs Systems , encompassing both… more
- Eliassen Group (Indianapolis, IN)
- …triage and troubleshooting. + Develop business processes and solutions to ensure quality , cost-effectiveness, and regulatory compliance . + Coordinate with ... **Business System Analyst** **Anywhere** **Type:** Contract **Category:** Business Analysis...to meet business goals. + Work in phases of systems analysis, considering the business implications of technology applications.… more
- Lilly (Indianapolis, IN)
- …of tools and systems , where applicable and stay informed of technological advances. ** Regulatory and Quality Compliance :** + Perform work in full ... statistical analysis plans, write reports and communicate results, assist/respond to regulatory queries. + Assist in and/or be accountable for selecting statistical… more
- J&J Family of Companies (Indianapolis, IN)
- …+ In collaboration with cross-functional team members, compile, prepare, review and submit high- quality regulatory submissions to authorities on time in US and ... regulatory input for product recalls and recall communications. + Support quality system and technical file/design dossier audits. + Maintain regulatory… more
- Cook Medical (Bloomington, IN)
- …including input on change requests, etc.- Maintain and organize appropriate regulatory records to demonstrate compliance with applicable regulations.- ... Overview The Regulatory Affairs Specialist I at Cook Inc. is...opportunities for continuous development and growth.- Adhere to the Quality Management System and its processes to… more
- System One (Indianapolis, IN)
- …seamless project integration. + Review the installation of designed equipment and systems to ensure compliance with construction documents and industry ... Electrical Engineer - Building Systems Candidates can work in Indianapolis or South...get work done more efficiently and economically, without compromising quality . System One not only serves as… more
- Lilly (Indianapolis, IN)
- …+ Engage with external committees to develop and influence industry standards, processes and tools Regulatory and Quality Compliance : + Perform work in full ... Communication of Results and Inferences: + Assist or respond to regulatory queries working in collaboration with other statistical colleagues. Therapeutic Area… more