The Quality Engineer is responsible for planning, coordinating and managing through completion, assigned projects to ensure the development and production of products meets customer and internal quality deliverables. Coordinate and lead investigations regarding customer complaints. Work with Supply Chain management to evaluate and manage supplier performance. Duties and responsibilities are accomplished personally or through collaboration with other staff.
- coordinate and execute Quality objectives throughout the company in cooperation with other departments, to maximize product quality and operating system efficiency/effectiveness while minimizing cost
- Prepare Site Master File, Quality Manual , DMF , DHF and technical file documents . VMP . KPI reporting
- Manufacturing Start up approval , incoming Quality , In process Quality and final Product release , BMR approval , document /records and sample retention .
- Coordinate and manage the execution of validations and creation of written protocols of the production and quality equipment and its ancillaries .
- Coordinate and manage the execution of change control /Document control activities and entire QMS Documentation and the process . Training and Audits .
- Assess results of Customer Complaint investigations and Corrective Actions for application, validity and conformance to , cGMP ,FDA regulatory, QSR, ISO and Customer requirements.
- Utilize CAPA problem solving techniques to reduce internal and external failures, selects sound techniques (FMEA, Design of Experiments, Cause and Effect, Flow Charts, SPC) to solve problems effectively, and assess results for application, validity and conformance to specifications.
- Develop and analyse statistical data in relationship to assigned tasks to determine adequacy of present standards and establish proposed quality improvements, including analysis of current inspection methods and sample plans.
- Develop product specifications for existing products and assess existing specifications for accuracy and compliance.
- Plan, coordinate, and manage assigned Supplier Quality evaluations through scheduling and auditing of suppliers.
- Support implementation and management of quality agreements with assigned suppliers.
- Plan, promote, perform and organize training activities for internal departments related to quality activities, including basic statistics, DOE, GR&R and Sample Plan designation.
- Interact with customers to assure mutual interpretation of specified requirements to ensure fulfilment of customer requirements and objectives are met.
- Manage customer audits and lead to final resolution any findings/observations resulting from the audits and prepare compliance .
- Assist in implementing &maintaining ISO 13485, ISO 15378 , ISO 14001 , ISO 45001 and FDA 21 CFR 820 QSR quality systems compliance.
- Support and maintain all policies of the company, including but not limited to applicable FDA regulatory and ISO requirements, Health and Safety Requirements and Continuous Improvement initiatives.
- Identify and complete continuous improvement projects utilizing Six Sigma tools and methodologies.
- Measure dimensions of products to verify conformance to specifications, using measuring instruments such as rulers, callipers, gauges, micrometres, force gauges, thickness gauges CMM , optical gaging machines, Vacuum Decay tester , torque tester , MFI , ESCR , FTIR , Moisture analyser , etc . Perform Gauge R&R .
- Other duties as assigned.
- Associate or Bachelor’s degree in Engineering, Science or related field.
- 3+ years’ of experience in a Quality position strongly preferred.
- Experience in the Medical Device industry strongly preferred (ISO13485)
- Experience with technical writing, IQ/OQ/PQ is preferred
- Experience with equipment validation is preferred
- Experience working onsite in Manufacturing is strongly preferred
- Excellent communication skills with the ability to understand, read, write and speak English required.
- Must have the ability to apply advanced mathematical concepts and intermediate statistical (SPC) knowledge.
- Six-sigma experience, training or certification preferred.
- Intermediate level computer skills, including Microsoft Office applications required.
- SAP /QMS software QT9 or similar one experience preferred.
- Ability to work independently from verbal and/or written instructions required.
- Ability to understand and articulate how individual role and responsibilities tie into Quality department function, goals and objectives
- Works in a clean manufacturing environment that may include moderate noise levels and required appropriate PPE and cleanroom apparel.
- Ability to regularly lift up to 30 lbs with repetitive movements.
- Ability to push and pull items.
- Ability to stand, sit, walk up to 80% of a shift.
- Ability to travel to supplier and customer locations .
- Job Identification 1001
- Job CategoryQuality& Regulatory Affairs
- Posting Date12/09/2023, 17:00
- Degree LevelBachelor’s Degree
- Job ScheduleFull time
- Locations 4955 , Avalon Ridge Pkwy , Norcross , Atlanta GA 30071