Quality Assurance Manager - 19428

Quality Assurance 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 Quality Assurance Manager with a biopharmaceutical company in San Diego, CA who possesses:   
  

• Must have strong ISO 13485 and cGMP experience
• Must have External Audit experience 
• Experienced in managing a quality team for a medical device manufacturing company a plus
• Bachelor's degree in a scientific discipline preferred 

Email resumes to kbrace@simplybiotech.com or call 858.683.8559 
  

FULL DESCRIPTION: Develops, coordinates, and implements quality management programs required for the development, approval, and successful manufacture of products. Leads the organization through the Quality System Regulation (21 CFR 820), and the European In-Vitro Diagnostic Regulation (2017/746) and the European quality management system standard (ISO 13485:2016). Oversees activities to assure successful certification audits as required. Monitors manufacturing, development, and quality processes to ensure conformance and compliance with all FDA and applicable international regulations. Leads domestic and international product registrations working directly with local customers and distributors. Manages corporate document control program and systems.

The selected candidate will be responsible for: 

• Leads the Quality organizations personnel. 
• Designs, establishes, and implements a site quality management system, based on FDA and applicable international regulations. 
• Manages the Corrective and Preventative Action Program. 
• Designs and implements programs ensuring compliance with the IVD Directive and IVD Regulation as required. 
• Monitors compliance with all FDA and applicable international quality management system regulations. 
• Ensures compliance with all Quality objectives for all product development teams. 
• Conducts Internal Audits and manages Internal Audit Schedule. 
• Provides Metrics for Quality Monitoring/Management Review. 
• Responsible for compliance with the company's quality system requirements through training and adherence to policies, procedures, and processes. 
• Provides regulatory and quality guidance to Operations and Product Development. Quality Assurance Manager 
• Oversees processes involved in maintaining annual licenses, registrations, listings, and patent information. 
• Manages product Registrations, working directly with representatives, customers, and distributors. 

The selected candidate will also possess:  

• B.S. degree in a scientific discipline or equivalent experience with a minimum of eight years related experience in a medical device or in-vitro diagnostic field with instrumentation experience desirable. 
• A minimum of 3 years in a supervisory/decision making role. Demonstrated proficiency with Quality Systems Regulation, 21 CFR 820, IVDR 2017/746 and ISO13485:2016 requirements. 
• Experience improving and managing quality management systems. 
• Must have proven managerial and interpersonal skills. 
• Experience conducting internal and supplier audits, inspections of manufacturing facilities. 
• Requires excellent verbal and written communication skills. 

Salary Range: $100k-$120k/yr  

For immediate and confidential consideration, please email your resume to kbrace@simplybiotech.com or call 858.683.8559 More information can be found at www.simplybiotech.com