Quality Assurance and Compliance Leader
2 weeks ago
The 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 regulations across all sectors.
Key Responsibilities:
- Formulate and implement regulatory strategies
- Act as the primary contact for FDA communications
- Facilitate audits by FDA and other regulatory bodies, ensuring timely completion of annual registrations
- Evaluate the necessity for regulatory registrations
- Oversee all quality procedures and associated documentation
- Manage the document control process, ensuring efficient handling of all documentation required by regulatory authorities; provide insights for ongoing improvements 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 proper implementation of the QMS
- Oversee corrective and preventive action protocols
- Deliver continuous training across the organization on FDA and ISO standards.
- Ensure that all quality and regulatory policies and procedures are thoroughly documented, executed, and communicated
- Supervise the complaint management process and the handling of nonconforming materials
- Manage supplier qualification processes and assess performance
- Stay informed and current on regulatory changes and requirements
Qualifications:
- High School Diploma is mandatory; a college degree is advantageous
- Preferred certification in Quality or Regulatory Systems; experience with FDA and ISO 23485 is beneficial
- Proficient knowledge and experience in technical writing and government submissions
- Project management experience is preferred
- Familiarity with Core platform or similar documentation software is desirable
- Exceptional verbal and written communication skills, capable of engaging effectively 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 domestically and internationally as the company expands (less than 15%)
-
Quality Assurance Leader
2 weeks ago
Louisville, Kentucky, United States WireCrafters, LLC Full timeJob 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 Leader
2 weeks ago
Louisville, Kentucky, United States WireCrafters, LLC Full timeJob 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...
-
Quality Assurance and Compliance Manager
2 weeks ago
Louisville, Kentucky, United States MAGNA WAVE Inc Full timePosition OverviewThe 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...
-
Quality Assurance Manager
1 week ago
Louisville, Kentucky, United States Zeochem LLC Full timeAbout 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 Coordinator
5 days ago
Louisville, Kentucky, United States Zeochem LLC Full timeJob 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
4 days ago
Louisville, Kentucky, United States Zeochem LLC Full timeJob 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 Specialist
5 days ago
Louisville, Kentucky, United States Multi-Color Corporation (formerly Fort Dearborn) Full timeAbout 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 Coordinator
7 days ago
Louisville, Kentucky, United States Zeochem LLC Full timeJob 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
7 days ago
Louisville, Kentucky, United States Zeochem LLC Full timeJob 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
6 days ago
Louisville, Kentucky, United States Zeochem LLC Full timeJob 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
4 days ago
Louisville, Kentucky, United States Zeochem LLC Full timeJob 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
7 days ago
Louisville, Kentucky, United States USWM, LLC Full timeJob 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
2 weeks ago
Louisville, Kentucky, United States MEDVANTX Full timeQuality 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 Engineer
2 weeks ago
Louisville, Kentucky, United States Waystar Full timeABOUT THIS ROLEWe are currently seeking a talented and motivated Senior Quality Assurance Engineer to enhance our expanding team. The Senior Quality Assurance Engineer is tasked with evaluating the company's offerings to guarantee compliance with established standards and specifications. Key responsibilities encompass executing test scenarios, developing and...
-
Quality Assurance Systems Leader
5 hours ago
Louisville, Kentucky, United States ORR Corporation Full timeKEY RESPONSIBILITIES All team members are expected to embody the mission of ORR Corporation, ensuring the safety of individuals, assets, and the environment in every aspect of their role. Oversee and manage the Quality Management System within the organization. Evaluate data and feedback to propose enhancements for the Quality system. Engage with...
-
Senior Quality Assurance Engineer
2 weeks ago
Louisville, Kentucky, United States Waystar Full timePOSITION OVERVIEWWe are currently seeking a highly skilled and motivated Senior Quality Assurance Engineer to enhance our expanding team. The Senior Quality Assurance Engineer plays a crucial role in evaluating the company's products to ensure compliance with established standards and specifications. Key responsibilities include executing test scenarios,...
-
WMS Quality Assurance Specialist
10 hours ago
Louisville, Kentucky, United States Natsoft Full timeDear Candidate,We are seeking a highly skilled Quality Assurance Specialist to join our team at Natsoft. As a WMS QA Specialist, you will play a critical role in ensuring the quality and reliability of our Warehouse Management System.Key Responsibilities:Implement and maintain quality assurance processes to ensure the WMS meets the required standards.Develop...
-
Senior Quality Assurance Specialist
5 days ago
Louisville, Kentucky, United States Congo Brands Full timeJob DescriptionAbout Congo BrandsCongo Brands is a leading consumer product company that specializes in the development and manufacturing of health and wellness products, including supplements, fitness snacks, hydration drinks, and energy drinks. Our company is committed to providing high-quality products that meet the evolving needs of consumers.The RoleWe...
-
Senior Quality Assurance Specialist
2 weeks ago
Louisville, Kentucky, United States BrightSpring Health Services Full timeQUALITY 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 timeCompany 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...