Quality Manager

Company Info
Southern Recruiting Solutions, Inc.
FL, United States

Phone:
Web Site: http://www.southernrs.com/

Company Profile
col-narrow   

Title:

Quality Manager

Location:

Greenville, SC 

Salary:

$110K-$135K

Job ID:

58698
col-wide   

Job Description:

Responsibilities
  • The Quality Manager is responsible for leading quality engineering team for design, development transfer, QA manufacturing and post-market surveillance of FDA Class I and II, EU Class I, IIa, IIb and III medical devices in the achievement of company goals.
  • Manages Quality Supervisors, Quality Engineers and Quality Assurance Technicians assigned to design and operation support activities to provide timely and efficient flow of services and projects.
  • Maintains a leading edge understanding of the quality processes required in designing, manufacturing and post market performance of arthroscopic, orthopedic devices and capital equipment in order to find new and novel opportunities to improve product quality and reduce cost.
  • Effectively implements enhancements and improvements as necessary to ensure maintenance of state-of-the-art processes and compliance to pertinent international standards and regulatory requirement, e.g., ISO 13485, 21 CFR 820, European MDR, etc.
  • Relocation provided. $110K-$135K.

Requirements
  • The Quality Manager will have a BS degree with an engineering major and 10+ years of medical device manufacturing experience. 3+ years in quality management.
  • Working knowledge of ISO and FDA quality requirements.
  • Technical knowledge in development methodologies, design quality analysis, and project implementation of medical devices and supporting accessories.
  • Must be legally eligible to work in the US without sponsorship.