QA Manager - 16825

QA Manager - Simply Biotech 

OVERVIEW 

Are you looking for a new career opportunity with an exciting biotech company?! Then we've got the right team for you! In this role, you're responsible for the duties listed below. 

Immediate opening for a QA Manager, in Princeton, New Jersey, who possesses: 

• BS/BA Degree in a related discipline 
• 3-5 years experience with ISO 13485 
• Previous experience implementing, running and updating a QA system.  
• Prior supervisory experience is preferred. 

FULL DESCRIPTION: 

The qualified candidate develops, coordinates, and implements quality management programs required for the development, approval and successful manufacture of products. Leads the organization through the European quality management system standard. Monitors manufacturing, development, quality, and regulatory processes to ensure conformance and compliance with all FDA and applicable international regulations.  Related activities include compiling and writing FDA reports as well as coordinating the completion of technical file requirements across multiple departments. Leads domestic product registrations working directly with local customers and distributors. Manages corporate document control program and systems. 

The candidate will also be responsible for: 

• Responsible for maintaining and updating interval processes and activities to meet Quality/Regulatory requirement; 
• Working closely with product team on maintaining and improving product and process quality, as well as on submission activities for US 510(k); 
• Participate in FDA inspections; 
• Responsible for Quality related internal training 

The selected candidate will also possess:   

• Must have 3-5 years of experience in Quality Assurance, preferably with a global manufacturer of medical devices including software 
• Successful experience in FDA 510(k) and inspection 
• Must have strong knowledge of compliance with FDA QSR and ISO 13485 
• Working knowledge of EU MDR and regulatory requirement in Asia a plus 
• Must have excellent written and verbal communication skills 

For immediate and confidential consideration, please email your resume to kchaney@simplybiotech.com or call 858.427.0687 

More information can be found at www.simplybiotech.com