| Job description: |
Quality Engineer
Greenville, SC
Salary $55K - $65K DOE
Major multi-billion dollar corporation with nearly 14,000 employees worldwide in the field of life sciences has opening in the South Carolina manufacturing facility for a quality engineer to provide manufacturing and validation process support. Our history of innovation continues as we invent new materials, engineer new technologies and create pioneering ways in our selected industry. As part of our research team you will report directly to the Quality Manager and have the following responsibilities:
1. Analyze problems, determine root causes, and take effective corrective action; work with manufacturing and production engineers for process improvement; implement quality tools that will allow process monitoring and improvement; work with manufacturing supervisors for the improvement of process and product quality metrics; reduce the number of reoccurring problems and help meet the company's quality objectives all in accordance with documented procedures and practices.
2. Write and review Non-Conformance Materials Review to verify discrepancy and adequacy of response to corrective action request.
3. Support continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program).
4. Participate on the Process Improvement Teams for internal, customer and supplier processes.
5. Streamline the Quality Management system by improving existing procedures or documents, and implementing new processes that lead toward a lean supply chain.
6. Ensure process efficiency and compliance effectiveness through support of process verification and validation plans.
7. Effectively use a variety of Quality and Continuous Process Improvement tools to drive continuous improvement activities (FMEA, Fault Tree Analysis, Lean Manufacturing, 5S, DOE, Gauge R&R, etc.)
8. Ensure compliance through the development of simple yet comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other related documentation.
Experience Required:
Ø Minimum 5 -10 years Quality Assurance/Quality Engineering experience in the medical device or pharmaceutical industry, with demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, and manufacturing / production process control methodologies. Aseptic experience is required.
Ø Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including, but not limited to, 21CFR 210, 211, and 820, EN 552 and ISO 9001/13485.
Ø Experience with and knowledge of the principles of lean methodologies and Six Sigma highly desirable.
Ø Excellent communication and strong computer skills.
Ø Strong written, verbal, analytical and interpersonal skills.
Ø Self-motivated.
Ø Ability to multi-task. Time management and organizational skills.
Education Required:
Bachelor of Science (minimum) in Engineering, Science or other technical field (preferred)
American Society for Quality, Certified Quality Engineer (CQE) preferred.
Training or certification in Six Sigma and Lean Methods
Relocation subsidy available for candidates who are not local to the area.
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