QMS & Regulatory Affairs Associate

Scope of Position

Develop and support all Quality Management System (QMS) / Regulatory Affairs (RA) activities and functions supporting the quality goals and quality metrics for Mediatech Inc. dba J R Scientific (JRS). Responsible for new product setup, quality project management, and regulatory compliance of serum products. Ensure compliance to in-house and/or external specifications and standards such as cGMPs, 21 CFR 820, ISO 13485, and Quality System Procedures.

Day-to-Day Responsibilities

• Ensure compliance to new and changing regulations affecting JRS products and processes including, but not limited to, QSR’s, global import/export regulations, etc.  
• New product setup and management of related projects 
• Maintain supplier quality assessment records and interface with serum suppliers.
• Assist with Supplier audits, as needed
• Collaborates with USDA on regulatory compliance activities including regulatory approvals, import/export compliance, traceability, quarantine, safety testing and affidavits.  
• Serve as a resource for customer’s regulatory and technical inquiries 
• Ongoing maintenance of JRS’ ISO 13485 based quality system  
• Implement and handle CAPA (Corrective and Preventive Actions) and problem resolution. 
• Coordinates and leads Quality Documentation, Nonconformance Reports, Inspection Activities, and Product Disposition.  
• Coordinates the review and revision of procedures, specifications, and forms to maintain and improve the QMS.  
• Assist with Quality Help Desk and customer complaint point of contact and problem resolution including Questionnaires, Certificates and Customer Surveys, etc. 
• Perform Internal Audits in support of internal requirements, 21 CFR 820 and ISO 13485 compliance.  
• Assists in representing JRS in customer quality audits, supplier quality audits and regulatory inspections  
• Performs investigations and analysis activities to support resolution of quality issues.  
• Collaborates with organizational teams to support quality system implementation.  
• Creation of new product master files satisfying customer and quality system requirements  

Additional Responsibilities

• Ensures quality standards by following company & departmental policies & procedures including, but not limited to:  
  • Product performance & quality verification.  
  • Identifying, recording, and investigating problems related to product, process & quality systems.  
  • Evaluating processes for improvements and standardization.  
  • Initiating action to prevent non-conformance in products, process, and quality systems.  
• Training on quality systems and applicable regulations as identified by supervisor and required by position.  
• Tracking/trending aspects of the QMS.  
• Other job duties as required 

Experiences/Education - Required

• Minimum of Bachelor’s degree in Science, Engineering, Bioengineering or related field.  Prefer Chemistry or Biology degree programs.
• Thorough knowledge and practical application of Quality Systems Regulations 21 CFR 820 and ISO 13485  
• Ability to develop, update and train on SOPs.  
• Working knowledge of ISO standards and Quality Management Systems (QMS).  
• Problem solving techniques to perform investigations and drive root cause analysis.  
• Related work experience performing internal/external audits.  
• Ability to monitor the QMS such as: Change Control, CAPA, Complaints, Nonconforming Materials and Products.  
• Experience with Continuous Improvement, Lean or Six Sigma. 

Experiences/Education - Desired

• Minimum 3 years’ experience in Quality or Regulatory, preferably in a medical device, pharmaceutical or biotechnology environment/industry. 
• SAP, EtQ and/or PeopleSoft experience.  
• Experience with statistical analysis.  
• Project management experience.  
• Animal by-product import/export regulations 
• Animal health and/or virology, immunology, epidemiology knowledge