Join our Quality team in Marietta, GA. As a Quality Engineer, you will ensure that a proactive and ongoing improvement quality system is established within the company; supervising quality standards to ensure we provide consistent, high-quality products and services. You will manage all aspects of quality, such as quality improvement, data analysis, product testing management, standards and documentation management, and supplier management. You will maintain an excellent working knowledge of cGMP, QSR, CMDCAS, ISO, MDD, and MDR regulations, ensuring that all design files are compliant.
In this role, you will lead quality activities required to support existing products and new product development. That includes leading change management, ensuring compliance with customer and regulatory requirements and ensuring that all design files meet the cGMP, ISO, MDD, and MDR regulations. You will also develop and implement quality procedures, process controls, and test methods for life cycle and new products. You will maintain product design files by managing existing product specifications and incoming inspection criteria. Additionally, you will manage our calibration program, which includes scheduling, record-keeping, and performing preventive maintenance on equipment. A crucial aspect of this role will be to maintain records, labels, SOPs, the Quality Manual, and related procedures.
Additional Responsibilities:
- Maintain an excellent working knowledge of the cGMP’s and the QSR, CMDCAS, ISO, MDD, and MDR regulations
- Maintains records, labels, SOPs, Quality Manual, and procedures
- Partner with R&D and other cross-functional groups to support the proper application of design controls, process validation, risk management, and the investigation/correction of design failures/challenges
- Equipment Validation and Re-validation
- Assist with internal and external audits
- QRB (Quality Review Board)
- Environmental Control
- Sterility Assurance Program
- cGMP’s and CAPA’s
- Assist in the establishment of company policies that will ensure the effective operation of the company
- Maintain equipment standard operating procedure development and training
- In the absence of all QA personnel, responsible for the release of finished goods
- Promote awareness of quality and regulatory compliance standards; ensure awareness of customer requirements throughout the organization
- Bachelor’s degree or equivalent in Engineering or science field or equivalent work experience
- Minimum of 5 years of hands-on experience in root cause analysis, project management, and continuous improvement in a regulated environment; preferably in an FDA regulatory industry (i.e., medical device, pharmaceutical, biomedical field) with an in-depth knowledge of current Good Manufacturing Practices, Quality System Regulations, and ISO Standards
- Experience with the FDA Quality Management Systems
- Experience in process validations
- Experience conducting design controls, validations, and calibrations
- Proficient with Onshape or other similar product development platforms; SAP, AutoCAD
- Ability to read drawings and 3D CAD models
- Excellent Project Management skills; ability to discern and prioritize projects with changing and competing deadlines
- Excellent organizational skills and attention to detail
- Ability to work independently and in a fast-paced environment and anticipate work needs
- Excellent written and verbal communication skills; ability to interact professionally with customers and suppliers
