Quality Systems Manager

Company: Sterling St James LLC
Location: Opelika
Posted on: November 16, 2021

Job Description:

Expanding company at their high volume manufacturing site in an attractive east central AL location has an opportunity for a Quality Systems Manager that is responsible for administering improvements within the Quality System to addressissues and trends effectively and in compliance with regulatory requirements and standards. The Quality Systems Manager will lead a team of professionals to manage various aspects of the Quality System and to achieve overall business unit metrics, provide Quality representation and support related to Quality Systems and production changes, customer management, and equipment qualification and support. Will supervise from 5 to 10 people. Benefits begin first day of employment and relocation assistance is available.Duties and Responsibilities

• Manage Document Control, support BHR Review, and other functions to help ensure departmental coverage
• Review document changes to ensure compliance with the Quality System; develop quality systems andprocedures as needed
  • Manage Internal Audit, CAPA/Complaint, and Supplier Quality programs
  • Analyze Internal Quality, CAPA/Complaint, Supplier Quality defect data to define and resolve root causes
  • Prepare reports by collecting, analyzing, and summarizing data
  • Ensure compliance to regulatory and customer requirements
  • Oversee training program in production practices and quality assessment of goods
  • Monitor, analyze and report effectiveness of quality system
  • Support the implementation of continuous improvement initiatives for productive processes; participate in cross-functional team environments to address CAPA and continuous improvement activities
    • Ensure adequate corrective and preventative actions are identified and implemented
    • Comply with all work rules including those pertaining to safety, health, and SiO2 QMS
    • Lead a team of support personnel
    • Excellent organizational skills to ensure a clean and orderly work environment
    • Proficient use in Microsoft Office Suite
    • Other duties as assignedRequired Skills/Abilities
      • Formal training in Quality-related fields and ASQ or similar certification as Quality Technician or Quality AuditorpreferredKnowledgeable of FDA Quality System Regulations (21CFR Part 820) and ISO 13485 as applicable tomanufacturing environments that produce components or devices for the medical industry
        • Demonstrated ability to implement and administer quality programs and interpret CAPA/Complaint data to drivecontinuous improvement
          • Proficient use in Microsoft Office Suite; knowledge/experience in Microsoft Visio and Project a plus
          • Strong ability to change approach/method to maximize efficiency
          • Strong attention to detail with good documentation practices
          • Ability to follow detailed instructions quickly and effectively
          • Thorough knowledge of Lean Six Sigma manufacturingQuality experience in either the medical device or the pharmaceutical industry

Keywords: Sterling St James LLC, Columbus , Quality Systems Manager, Executive , Opelika, Georgia