Quality Assurance and Compliance Manager

2 weeks ago

Louisville, Kentucky, United States MAGNA WAVE Inc Full time
Position Overview

The Quality Assurance and Compliance Manager is responsible for overseeing, auditing, and enhancing the MagnaWave Quality Management System (QMS). This role entails managing the organization's registrations, applications, and preparedness for entering new markets, both domestically and internationally, while ensuring adherence to standards and regulations across all markets.

Key Responsibilities:

  • Formulate regulatory strategies to ensure compliance
  • Act as the primary contact for FDA communications
  • Facilitate audits conducted by FDA and other regulatory bodies, and complete annual registration processes
  • Evaluate the necessity for regulatory registrations
  • Oversee all quality procedures and related documentation
  • Manage the document control process, ensuring efficient management of all documentation required by regulatory authorities; provide insights for continuous improvement in document change control and retention practices.
  • Conduct scheduled audits of quality procedures and documentation to verify compliance
  • Perform internal reviews and audits to confirm the effective implementation of the QMS
  • Administer corrective and preventive action protocols
  • Provide ongoing training across the organization regarding FDA and ISO standards.
  • Ensure that all quality and regulatory policies and procedures are thoroughly documented, implemented, and communicated
  • Oversee the complaint management process and the handling of nonconforming materials
  • Manage supplier qualification processes and monitor supplier performance
  • Stay informed and updated on relevant regulations

Qualifications:

  • High School Diploma is mandatory; a college degree is preferred
  • Certification in Quality or Regulatory Systems is advantageous; experience with FDA and ISO 23485 is beneficial
  • Proficiency in technical writing and government submissions is desirable
  • Experience in project management is preferred
  • Familiarity with Core platform or similar documentation software is beneficial
  • Exceptional verbal and written communication skills, capable of effectively engaging with all organizational levels

Physical Requirements:

  • Frequent sitting or standing for extended periods may be required
  • Ability to push, pull, or lift objects weighing up to 50 lbs.
  • Willingness to travel (domestic and international) as the company expands (less than 15%)

  • Quality Assurance Manager

    7 days ago

    Louisville, Kentucky, United States Zeochem LLC Full time

    About the RoleZeochem LLC is seeking a highly skilled Quality Assurance Manager to oversee the quality assurance program for its chemical manufacturing facility.Key ResponsibilitiesManage and maintain quality assurance processes and procedures for the site quality systems.Lead local Quality Improvement Team (QIT) meetings to ensure effective implementation...

  • Quality Assurance and Compliance Leader

    2 weeks ago

    Louisville, Kentucky, United States MAGNA WAVE Inc Full time

    Position OverviewThe Quality Assurance and Compliance Leader is responsible for overseeing, evaluating, and enhancing the MagnaWave Quality Management System (QMS). This role involves managing the organization's regulatory registrations, applications, and readiness for entry into both domestic and international markets, ensuring adherence to standards and...

  • Quality Assurance Coordinator

    3 days ago

    Louisville, Kentucky, United States Zeochem LLC Full time

    Job SummaryZeochem LLC is seeking a highly skilled Quality Assurance Coordinator to oversee the quality assurance program for its chemical manufacturing facility. The ideal candidate will have experience with quality management systems, document control, and continuous improvement.Key ResponsibilitiesMaintain quality processes and procedures to ensure...

  • Quality Assurance Coordinator

    2 days ago

    Louisville, Kentucky, United States Zeochem LLC Full time

    Job DescriptionZeochem LLC is seeking a highly skilled Quality Assurance Coordinator to oversee the quality assurance program for its chemical manufacturing facility.Key Responsibilities:Maintain and implement quality assurance processes and procedures to ensure compliance with ISO 9001:2015 and other regulatory requirements.Lead the Quality Improvement Team...

  • Quality Assurance Coordinator

    5 days ago

    Louisville, Kentucky, United States Zeochem LLC Full time

    Job SummaryZeochem LLC is seeking a highly skilled Quality Assurance Coordinator to oversee the quality assurance program for its chemical manufacturing facility.Key ResponsibilitiesManage and maintain the company's quality assurance systems, ensuring compliance with regulatory requirements.Coordinate document control and implement a site-wide continuous...

  • Quality Assurance Specialist

    5 days ago

    Louisville, Kentucky, United States Zeochem LLC Full time

    Job SummaryZeochem LLC is seeking a highly skilled Quality Assurance Specialist to oversee the quality assurance program for its chemical manufacturing facility. The ideal candidate will have experience with quality management systems, document control, and continuous improvement.Key ResponsibilitiesMaintain quality processes and procedures for site quality...

  • Quality Assurance Coordinator

    4 days ago

    Louisville, Kentucky, United States Zeochem LLC Full time

    Job SummaryZeochem LLC is seeking a highly skilled Quality Assurance Coordinator to oversee the quality assurance program for its chemical manufacturing facility. The ideal candidate will have experience with quality management systems, document control, and continuous improvement.Key ResponsibilitiesMaintain quality processes and procedures for site quality...

  • Quality Assurance Coordinator

    1 day ago

    Louisville, Kentucky, United States Zeochem LLC Full time

    Job SummaryZeochem LLC is seeking a highly skilled Quality Assurance Coordinator to oversee the quality assurance program for its chemical manufacturing facility. The ideal candidate will have experience with quality management systems, document control, and continuous improvement.Key ResponsibilitiesMaintain quality processes and procedures to ensure...

  • Quality Assurance Director

    5 days ago

    Louisville, Kentucky, United States USWM, LLC Full time

    Job SummaryWe are seeking an experienced and highly motivated Senior Validation Manager to join our team at USWM, LLC. The ideal candidate will have a robust background in cGMP pharmaceutical manufacturing and GxP biotechnology, with extensive experience in data integrity, quality assurance, and regulatory compliance.Key ResponsibilitiesProvide leadership...

  • Quality Assurance Specialist

    3 days ago

    Louisville, Kentucky, United States Multi-Color Corporation (formerly Fort Dearborn) Full time

    About the Role:We are seeking a highly skilled Quality Assurance Specialist to join our team at Multi-Color Corporation (formerly Fort Dearborn). As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our products and services.Key Responsibilities:Perform on-line quality audits and raw materials testing to ensure...

  • Quality Assurance Leader

    2 weeks ago

    Louisville, Kentucky, United States WireCrafters, LLC Full time

    Job OverviewWireCrafters, LLC, a reputable manufacturer specializing in wire partitions, storage solutions, and safety barriers, is committed to delivering exceptional quality products and services. We are currently in search of a dedicated Quality Manager to enhance our manufacturing operations.Key Responsibilities:Serve as the process owner for ISO...

  • Quality Assurance Specialist

    2 weeks ago

    Louisville, Kentucky, United States MEDVANTX Full time

    Quality Assurance SpecialistShift: 10:30 AM - 7:00 PM CSTHYBRID ROLE REQUIRING 2-3 DAYS IN OFFICE PER WEEKJob OverviewAs a Quality Assurance Specialist at MEDVANTX, you will play a pivotal role in assessing and auditing quality-related incidents, interactions with patients and clients, as well as overseeing order placement and fulfillment processes. Your...

  • Senior Quality Assurance Manager

    1 week ago

    Louisville, Kentucky, United States Brooksource Full time

    Job DescriptionJob Title: Lead Quality Assurance EngineerCompany: BrooksourceJob Type: Contract to Hire/PermanentLocation: Remote (Louisville, KY)About the Role:We are seeking a highly skilled and experienced Lead Quality Assurance Engineer to join our team at Brooksource. As a Lead QA Engineer, you will be responsible for leading the testing of several...

  • Quality Assurance Leader

    2 weeks ago

    Louisville, Kentucky, United States WireCrafters, LLC Full time

    Job OverviewWireCrafters, LLC, a prominent manufacturer established in 1967, specializes in wire partitions, storage solutions, safety barriers, and various material handling products. Renowned for exceptional customer service and high-quality output, we are looking for a dedicated Quality Manager to enhance our manufacturing operations.Position Summary:The...

  • Senior Quality Assurance Specialist

    2 weeks ago

    Louisville, Kentucky, United States BrightSpring Health Services Full time

    QUALITY ASSURANCE ANALYST IIJob LocationsUS-KY-LOUISVILLEIDLine of BusinessBrightSpring Health ServicesPosition TypeFull-TimeCompany OverviewBrightSpring Health Services is dedicated to providing exceptional home and community-based pharmacy and health services tailored for complex populations requiring chronic and specialized care.Role OverviewThe Quality...

  • Quality Assurance Specialist II

    2 weeks ago

    Louisville, Kentucky, United States BrightSpring Health Services Full time

    Company OverviewBrightSpring Health Services is a prominent provider of integrated home and community-based pharmacy and health services, catering to complex populations requiring chronic and specialized care.Position SummaryThe Quality Assurance Analyst II is accountable for orchestrating Quality Assurance planning activities and executing QA testing on...

  • Quality Assurance Specialist

    2 weeks ago

    Louisville, Kentucky, United States JobRialto Full time

    Company Overview: JobRialto is committed to delivering exceptional quality in all our products and services. We are currently seeking a dedicated quality professional to join our team as a Quality Assurance Specialist. Position Summary: In this pivotal role, you will oversee the quality assurance processes for various products within a specific program area....

  • Construction Quality Assurance Manager

    1 week ago

    Louisville, Kentucky, United States The Walsh Group Full time

    Job DescriptionThe Walsh Group is seeking a highly skilled Construction Quality Assurance Manager to join our team. As a key member of our quality management team, you will be responsible for ensuring that our construction projects meet the highest standards of quality, safety, and efficiency.Key Responsibilities:Quality Champion: Lead and manage quality...

  • Quality Assurance Specialist

    1 week ago

    Louisville, Kentucky, United States BAE Systems Full time

    Job DescriptionWe are seeking a highly skilled Quality Assurance Specialist to join our team at BAE Systems. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our products and services.Key Responsibilities:Provide oversight of all aspects of product quality, including inspection methods, data collection, data...

  • Quality Assurance Specialist

    15 hours ago

    Louisville, Kentucky, United States BAE Systems Full time

    Job DescriptionWe are seeking a highly skilled Quality Assurance Specialist to join our team at BAE Systems. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our products and services.Key Responsibilities:Provide oversight of all aspects of product quality, including inspection methods, data collection, data...