Manufacturing Documentation Specialist: SOPs & Systems

Cook Medical Inc.; Bloomington (IN); On-site; USD 60,000 - 80,000; Full time

Job summary

Cook Medical Inc. is seeking a Manufacturing Specialist to provide technical support to operations, focusing on documentation, equipment procurement, testing, and training to ensure safe, quality production.

You will collaborate across functions, install and qualify equipment in production areas, develop manufacturing documents, support projects, and mentor teammates while upholding FDA 21 CFR 820 and ISO 13485 requirements.

Qualifications

• Experience working independently and with minimal supervision.

Responsibilities

• Independently produce, organize, and maintain documentation or systems critical to the function of the engineering team or department.
• Support short-term, long-term, and/or system-focused projects, or complete significant tasks critical to Cook, Inc projects.
• Installs and qualifies equipment in the production areas.
• Develop or revise documents and procedures such as Drawings, Work Instructions, and Standard Operating Procedures
• Prepare prototype work orders, develop manufacturing documentation, perform testing associated with manufacturing projects.
• Drive creation and implementation priority change orders within AgilePLM.
• Ability to work on multiple projects simultaneously, supporting documentation.
• Troubleshoot systems, and/or documentation issues, as needed.
• Use judgment and experience to independently accomplish project objectives.
• Maintain high knowledge level related to the team's focus and relevant company systems (Including jBase, AgilePLM, Opcenter).
• Serve as a mentor, trainer, and resource to the team within area of expertise.
• Identify areas for improvement and offer solutions.
• Prioritize work based on assigned goals
• Read, comprehend and follow product and packaging specifications and manufacturing instructions and drawings.
• Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
• Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory

Skills

Independent work

Education

AS/BS in relevant field

Tools

AgilePLM

Microsoft Office

Job description

Cook Medical Inc. is seeking a Manufacturing Specialist to provide technical support to operations, focusing on documentation, equipment procurement, testing, and training to ensure safe, quality production.

You will collaborate across functions, install and qualify equipment in production areas, develop manufacturing documents, support projects, and mentor teammates while upholding FDA 21 CFR 820 and ISO 13485 requirements.