Lead Quality Engineer

Meeting All Design Control And Other Regulatory Requirements.

• Support design control projects.
• Writes and leads risk management activities.
• Support the efforts in creation of specifications, design, and test methods for the new products.
• Translate customer needs into engineering requirements into specific product, packaging and process specifications.
• Write detailed technical reports based on design verification analysis/testing for design changes and product design activities
• Interface with manufacturing on an ongoing basis during the development stages to ensure manufacturability of the design solutions.
• Consistent application of technical principles, theories, concepts, and quality sciences /tools.
• Proven problem-solving skills
• Ensures that all design control and production / process control projects meet applicable regulatory (local and international), Corporate, and Unit requirements.
• Is a team member representing Quality on new product development and sustaining engineering projects.
• Reviews and has Quality Engineering approval authority for new and modified design /process specifications including product performance specifications, test methods, etc.
• Assists with supplier and internal quality system audits as a means of evaluating the efficiency of the established Quality System and Good manufacturing Practices.
• Support the implementation of new products, processes, and changes by developing quality plans, approval of validation plans and protocols, inspection methods, work instructions, and raw material specifications and inspection plans.
• Support manufacturing and quality process improvement projects as an effective team member or leader using Continuous Improvement and Six Sigma tools.
• Analyse and interpret inspection and process data to identify and prevent quality problems and continuous improvement opportunities.
• Responsible for the investigation, documentation, root cause, and corrective action activities of deviations and non-conforming material.
• Responsible for the investigation, documentation, root cause, and corrective action activities of customer complaints.
• Conduct Internal and Supplier Audits. Provide audit support for customer and regulatory audits (preparation, closure, etc.)
• Provides training for operations and engineering teams or best practices.
• Communicates across functions / departments for assigned areas of responsibility.
• Comply with all local, state, federal, and BD Safety regulations, policies, and procedures including RCRA Hazardous waste regulations
  

Required Skills