Quality Assurance Specialist
3 weeks ago
QUALITY ASSURANCE SPECIALIST
Oversees Quality Assurance activities to ensure compliance with regulatory agencies, ISO and company requirements. Performs all Document Control functions to assure compliance with the company quality system and contributes to the management of the electronic QMS system.
- Final review and sign off approval for new documents/new document revisions prior to distribution.
- Manages and tracks notifications and letters to customers related to product information, recalls, and complaint investigations.
- Manages and tracks complaint escalations submitted to manufacturing site, including dissemination of root cause and recommendations to internal teams and customers, as needed.
- Oversee CAP Proficiency Testing program, including testing surveys on in-house instruments and presenting testing data to internal teams.
- Final review of documents produced during instrument reception testing and where applicable final disposition authority for incoming materials, including packaging and labeling, used in product manufacturing.
- Oversees the Approved Vendor List, additions, and removals in accordance with regulatory requirements and internal procedures.
- Oversees the change order (CO) process and verifies that all changes are properly implemented. Responsible for tracking documents through the system. Maintains a master list of all controlled documents.
- Contributes to establishing document approval and change control procedures in addition to assisting other department personnel in formatting all quality system documents. Provide word processing services as required to prepare all such documentation.
- Manages electronic QMS and systems (Acts as system coordinator and SME)
- Conduct and assist as needed with the Internal Audit Program.
- Coordinates the Nonconformance Reports and Corrective and Preventive Action (CAPA) process to ensure compliance to regulatory and internal requirements and to ensure actions are completed in a timely manner. Manages the nonconformance handling system to ensure all nonconformities are identified, investigated, and entered in the CAPA system, if necessary
- Maintains the Training Program and assists with company awareness of the Quality System and provides support and training on Quality issues.
- Supports company infrastructure including facilities and equipment. Ensures validation, calibration and maintenance of these areas as required by regulations and internal systems (as applicable by site)
- Oversees the complaint process to ensure regulatory and internal requirements are met.
- Other duties as assigned by Director of Regulatory & Quality Affairs.
KNOWLEDGE: The position requires excellent knowledge of FDA and international regulations, directives and standards governing medical devices.
EXPERIENCE: This position requires a minimum of five (5) years’ experience in Quality Assurance or Regulatory Affairs in an FDA regulated industry plus a Bachelor's Degree.
This is role is based in Norcross, GA - no relocation provided.
-
Quality Assurance Specialist
4 weeks ago
Norcross, United States Sebia USA Full timeQUALITY ASSURANCE SPECIALISTOversees Quality Assurance activities to ensure compliance with regulatory agencies, ISO and company requirements. Performs all Document Control functions to assure compliance with the company quality system and contributes to the management of the electronic QMS system.Final review and sign off approval for new documents/new...
-
Quality Assurance
2 months ago
Norcross, United States ComSonics Full timeJob DescriptionJob DescriptionAre you looking for a great place to work? Cable Connections, a division of ComSonics, Inc., is the place for you! We are looking for someone experienced in Quality Assurance who will be responsible for providing inspection of wire and cable assemblies to insure conformance of product to established guidelines.Qualified...
-
Quality Assurance
3 weeks ago
Norcross, United States ComSonics Full time $16Job DescriptionJob DescriptionAre you looking for a great place to work? Cable Connections, a division of ComSonics, Inc., is the place for you!We have a great opportunity for someone experienced in Quality Assurance / Inspections who will be part of our Quality Operations team.During your work day you will complete final inspections and acceptance of...
-
Quality Assurance Compliance Specialist
7 days ago
Norcross, Georgia, United States GeorgiaGov Full timeQuality Assurance Utilization Coordinator (Bilingual) - APEX ProgramThe APEX Program represents an innovative effort aimed at providing outstanding services to students throughout the state. This initiative is supported by the Georgia Department of Behavioral Health and Developmental Disabilities (DBHDD) along with various educational institutions.Key...
-
Quality Assurance Compliance Specialist
2 weeks ago
Norcross, Georgia, United States GeorgiaGov Full timeQuality Assurance Utilization Coordinator (Bilingual) - APEX ProgramThe APEX Program represents an innovative approach aimed at providing outstanding services to students throughout Georgia. This initiative is supported by the Georgia Department of Behavioral Health and Developmental Disabilities (DBHDD) in collaboration with various educational...
-
Quality Assurance Analyst
7 days ago
Norcross, Georgia, United States Sebia USA Full timeQUALITY ASSURANCE ANALYSTThe Quality Assurance Analyst is responsible for supervising Quality Assurance functions to guarantee adherence to regulatory standards, ISO guidelines, and internal company protocols. This role encompasses all Document Control responsibilities to ensure compliance with the organization's quality management system and aids in the...
-
Quality Assurance Analyst
7 days ago
Norcross, Georgia, United States Sebia USA Full timeQUALITY ASSURANCE ANALYSTResponsible for overseeing Quality Assurance functions to guarantee adherence to regulatory standards, ISO guidelines, and internal protocols. Executes all Document Control responsibilities to ensure compliance with the organizational quality framework and aids in the management of the electronic Quality Management System...
-
Quality Assurance Leader
2 weeks ago
Norcross, Georgia, United States Micromeritics Full timeJob OverviewSalary: CompetitiveJoining MICROMERITICS means contributing to advancements that enhance our world. Our innovative products provide solutions for characterizing particles, powders, and porous materials, emphasizing their physical properties, chemical activity, and flow characteristics. Our cutting-edge technology portfolio includes instruments...
-
Quality Control Specialist
2 weeks ago
Norcross, Georgia, United States ComSonics Full timeJoin Our Team at ComSonicsComSonics is currently in search of a skilled Quality Control Specialist to enhance our quality assurance department.The successful candidate will play a crucial role in evaluating wire and cable assemblies to ensure compliance with set standards.Key Responsibilities:Conduct thorough visual assessments of wire and cable...
-
Quality Assurance Systems Associate
2 days ago
Norcross, Georgia, United States Ole' Mexican Foods, Inc Full timeJob Summary:Ole' Mexican Foods, Inc is seeking a highly skilled Quality Assurance Systems Associate to join our team. As a key member of our Quality Assurance department, you will play a crucial role in maintaining and enhancing our quality assurance processes across the organization.Key Responsibilities:Data Management:Maintain and update our corporate...
-
Quality Assurance Manager
2 weeks ago
Norcross, United States Micromeritics Full timeJob DescriptionJob DescriptionSalary: POSITION SUMMARY:The Quality Assurance Manager works with the PTA Laboratory Manager and lab employees to make sure that PTA complies with ISO, FDA, CFR's, and GMP/GLP guidelines and that all appropriate documentation is maintained.ESSENTIAL FUNCTIONS:Perform quality reviews and approval of lab test data. Responsible...
-
Norcross, Georgia, United States GeorgiaGov Full timeQuality Assurance Utilization Coordinator (Bilingual) - APEX ProgramThe APEX Program represents a groundbreaking effort aimed at providing outstanding services to students throughout the state. This initiative is supported by the Georgia Department of Behavioral Health and Developmental Disabilities (DBHDD) along with various educational institutions.Key...
-
Quality Control Manager
4 days ago
Norcross, Georgia, United States Crosslink Employee Services LLC Full timeJob Summary**Job Type:** Full-time**Job Description:**We are seeking a highly skilled Quality Assurance Specialist to join our team at Crosslink Employee Services LLC. As a Quality Assurance Specialist, you will play a critical role in maintaining the quality management system of our organization, ensuring compliance with regulatory requirements and internal...
-
Quality Control Inspector
4 days ago
Norcross, Georgia, United States Cable Connections Inc Full timeJob Summary:We are seeking a highly skilled Quality Assurance Specialist to join our Quality Operations team at Cable Connections, a division of ComSonics, Inc.Key Responsibilities:Perform final inspections and acceptance of completed products to ensure they meet company standards and customer requirements.Verify correct and complete completion of...
-
Quality Assurance and Engineering Leader
2 weeks ago
Norcross, Georgia, United States ComSonics Full timeQuality/Engineering ManagerAn exciting opportunity is available for a Quality/Engineering Manager at ComSonics. This position is pivotal in steering the Quality, Engineering, and Quoting teams to uphold and improve product excellence, operational efficiency, and client satisfaction.Key Responsibilities:Oversee quality documentation and ensure adherence to...
-
Quality Assurance Utilization Coordinator
3 months ago
Norcross, United States GeorgiaGov Full timeAPEX Program is an innovative program that has been providing services to the students in the state of Georgia, supported by Georgia Department of Behavioral Health and Developmental Disabilities (DBHDD), and school systems. Under general supervision, compiles reports of indicators pertaining to potential fraud. Reviews system reports to determine state or...
-
Quality Assurance and Engineering Leader
7 days ago
Norcross, Georgia, United States ComSonics Full timeQuality/Engineering ManagerAn exciting opportunity exists for a Quality/Engineering Manager at ComSonics. This position is pivotal in steering the Quality, Engineering, and Quoting teams to uphold and improve product excellence, operational efficiency, and client satisfaction. Key responsibilities encompass supervising quality documentation, ensuring...
-
Sign Production Specialist
2 months ago
Norcross, United States FASTSIGNS #40101 Full timeJob DescriptionJob DescriptionBenefits:401(k)401(k) matchingBonus based on performanceCompetitive salaryFree uniformsHealth insurancePaid time off FASTSIGNS #40101 is hiring for a full-time Sign Production Specialist to join our team!Benefits/Perks:Competitive PayPaid Vacation and HolidayPerformance BonusOngoing Training OpportunitiesA Successful FASTSIGNS...
-
Consumer Care Specialist
3 days ago
Norcross, Georgia, United States Ole Mexican Foods, INC Full timeJob DescriptionOle Mexican Foods, INC is committed to delivering exceptional quality and freshness in our products. As a Consumer Care Specialist, you will play a vital role in ensuring that our customers receive the best possible experience.Key Responsibilities:Primary contact with consumers to address their feedback and concerns regarding our...
-
Quality Systems Management Associate
3 months ago
Norcross, United States Ole' Mexican Foods, Inc Full timeAt Ole, our mission is to produce the finest Authentic Mexican inspired products with an unwavering commitment to quality and freshness. We believe that holding a seat at your dinner table is the ultimate compliment, and we strive to help families create wholesome, fun, and authentic eating experiences. Job Summary: As a QA Systems Management Associate at...