Quality Systems Manager

Quality Systems Manager

28 Oct 2024
Georgia, Columbus, 31900 Columbus USA

Quality Systems Manager

Vacancy expired!

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 address
issues 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 and
procedures 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 assigned

Required Skills/Abilities
Formal training in Quality-related fields and ASQ or similar certification as Quality Technician or Quality Auditor
preferred

  • Knowledgeable of FDA Quality System Regulations (21CFR Part 820) and ISO 13485 as applicable to
    manufacturing environments that produce components or devices for the medical industry
    Demonstrated ability to implement and administer quality programs and interpret CAPA/Complaint data to drive
    continuous 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 manufacturing

Quality experience in either the medical device or the pharmaceutical industry

Job Details

  • ID
    JC21680251
  • State
  • City
  • Job type
    Full Time
  • Salary
    TBD
  • Hiring Company
    Gables Search Group
  • Date
    2021-10-23
  • Deadline
    2021-12-21
  • Category

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