Quality Engineer

Provide quality guidance, product resolution decisions, and statistical problem-solving techniques to manufacturing operations and project teams for new product introduction, process improvements, continuous improvements, and validation activities.

Day To Day Responsibilities

• Provide product team support including, Material Review Board (MRB), customer complaint activities, statistical analysis, validation support, inspection plans, metrology, quality metrics and report functions.
• Facilitate investigations, Situation Analysis (SA) and Health Hazard Evaluation (HHE) with clear documentation of corrective actions.
• Lead discussions on blocked stock and open notifications in Material Review Board (MRB).
• Assist with the investigation of Corrective & Preventive Actions (CAPA), notifications and customer complaints, providing solutions where possible. Communicate customer feedback to Quality Systems group.
• Work with functional groups to ensure changes proposed through the change management program have the proper technical review and that there is a risk assessment of requested changes.
• Apply quality engineering practices and guidance to support project teams and manufacturing operations using Six Sigma tools, FMEA, CE Diagram, CE Matrix, DOE, MSA, Validation Protocol development, review, approval and Control Plans.
• Support Continuous Improvement activities and key plant projects.
• Focus on cost avoidance and cost reduction activities that will contribute to a reduction in poor cost of quality (COQ).
• Develop/Revise Quality Plans including incoming, in-process and final inspection, and provide training to those affected by the plans.
• Implement validated inspection and metrology improvements and associated training.
• Create technical process documents that fit the business needs and maintain compliance to the regulatory requirements of the FDA and ISO standards.
• Serve as a resource for performing internal audits to ensure quality system compliance.

Education & Experience you’ll have:

• Bachelor’s degree in science, engineer or technical field. Engineering or Statistics preferred.
• Several years of experience in a manufacturing quality engineer position in a highly regulated industry