As the Nemedio Quality Engineer you will provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to ensure compliance. You will have direct experience with regulations governing medical devices, combination products and any other regulated products. Experience authoring  standard operating procedures (SOP's) to ensure compliance to CFR Part 820 and ISO 13485. Interface with Nemedio customers in aspects related to QMS structure, development and implementation. In addition, provide support to customers on their path to pursuit 510k and or EUA clearance, and help with the generation of technical documentation to support submissions when applicable.  As a Quality Engineer, you will have a minimum of 5 years of experience with Quality Affairs in a FDA regulated environment. You are experienced authoring quality documents (SOPs, WIs, templates, User Specifications, D&D Plans, Manufacturing Plans, IFUs, CQAs, TPPs, etc.) from scratch. You've led different teams and stakeholders through the QMS implementation methodology from initiation to completion in a medical device, combination product and any FDA regulated environment. You understand how to apply risk management principles to software products and are able to help guide our clients with best practices for product risk management and validation activities. Support quality management systems operation within the organization to ensure delivery and customer satisfaction. Ensure standard operating procedures are a use of to end users.

Job Responsibilities:

• Support Quality activities in as needed capacity (i.e. gap assessment, writing SOPs, v&v protocols, etc.).
• Developing a thorough understanding of Nemedio's philosophy,  products, and services
• As needed, support customers with on-boarding into the Nemedio's QualitySystem, including, but not limited to, helping author/revise Nemedio's SOPs, WI,  Forms, Templates, and validation documents. 
• Collaborate with the Design Team to support the design of Nemedio's  QMS Modules to understand interactions and expected operation to incorporate with Quality efforts. 
• Perform additional tasks as requested by management.

Key Qualifications for this role include:

• Minimum of 5 years of  experience  working in medical device and or  FDA regulated environment
• Expert in the Regulated industry in Quality Affairs Approach
• Knowledge of medical device technical documentation as D&D Plans, IFUs, User Requirements, Intended Use, etc.
• Expert in writing and authoring quality documents (SOPs, WIs, templates, Forms, URS, etc.) from scratch 
• Able to effectively communicate with different levels of Technical and non technical team members
• Understanding of how to apply risk management principles to software and may even be able to help guide our clients with best practices for product risk management.

Skill Set: 

You are experienced  and  knowledgeable working with:

• 21 CFR Part 820 
• 21 CFR Part 3/4
• 21 CFR Part 11
• 21 CFR Part 210/211
• ISO 13485
• ISO 14971
• EUA and 510k Exposure is a Plus
• Software Development for Medical Devices per IEC 62304- Preferred
• Agile software development- Preferred