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Senior Quality Assurance Supervisor

Your Role:

 

The QA Supervisor has three main areas of responsibility.

  • To manage the implementation and maintenance of cGMP and ISO 9001:2015 quality systems, and coordinate quality initiatives with Operations, R&D, and Marketing management to ensure we meet or exceed industry standards. Furthermore to champion continuous improvement opportunities within these systems and lead or facilitate those ongoing improvement efforts. Work with other departments, divisions, and sites to solve problems, assess risk, improve service, reduce costs, and enhance programs within the Quality Management System.
  • Ensure cGMP and ISO requirements are being met for both raw material and final product release.  Act as initial contact with customers or Sales requesting additional information for products, complaints, product status, or quality support. Manage and coordinate personnel to maintain adequately trained  resources to consistently review and release product in pace with Operations. Resolve and follow-up on major issues with manufacturing, QC, and/or packaging that result from discrepancies in expected quality. Monitor and ensure that proper procedures are being followed in Operations including; manufacturing, testing, packaging, and warehousing of products.
  • Develop quality employees that can respond to business and customer needs while maintaining the integrity of the Quality Management System. Advanced interpersonal skills with ability to act as a mentor  and coach to staff and co-workers. Evaluate employee performance against expected job requirements. Mentor employees in meeting or exceeding expected job requirements, by ensuring skills and knowledge development occurs to allow employees to maximize performance in current positions. Identify and develop those employees with the potential and interest to pursue further responsibilities. 

     

     

     

Who You Are:

 

Basic Requirements:

  • Minimum Bachelors degree (Chemistry, Biochemistry or Biology)
  • 6+ years of experience in Medical Device or API Quality aspects 
  • Strong leadership skills with a passion for personnel development

 

Preferred Requirements

  • Must possess a current understanding of the regulatory requirements governing Medical Devices, Pharmaceuticals, API’s and ISO Quality Management System Requirements 
  • Must understand Validation, Qualification, and be able to demonstrate effective use of problem solving techniques
  • Possess written and oral communication skills
  • Excellent organizational and time management skills required  
  • Excellent record of customer service with direct customer interaction
Job Requisition ID:  189617
Location:  St. Louis
Career Level:  D - Professional (4-9 years)
Working time model:  full-time


Job Segment: Biochemistry, Medical, Manager, Quality Manager, Science, Healthcare, Management, Quality

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