Quality Engineer

Duties And Responsibilities

• Establish and participate in supplier qualification/development activities.
• Lead/Develop/Use Key Process Indicators to determine process effectiveness, identify areas for improvement, best practices, and drive continuous quality improvement.
• Lead/Drive corrective, preventive, and closure actions for project issues related to quality and/or test non-conformance.
• Work closely with production line and ensure all necessary controls are enforced to be compliant with ISO 13485 and FDA QSR requirements.
• May ensure that quality reporting (e.g. incoming and in-process quality trends; returns analysis, categorization and corrective action activity, etc.) is maintained and documented with the assigned team.
• Perform analysis of reports and production data to identify trends and recommend updates to changes to the Quality System Regulations, Standards, and/or guideline procedures when necessary.
• Determines quality improvement parameters by identifying statistical methods relevant to manufacturing processes.
• Establishes statistical confidence by identifying sample size and acceptable error; determining levels of confidence.
• Develops sampling plans by applying attribute, variable, and sequential sampling methods.
• Maintains statistical process controls by applying demerit/unit, zone charting, and x2 charts for distributions and individual-medial/range for multi-stream processes.
• Analyzes data by completing hypothesis, normal distribution, and process capability analysis tests.
• Prepares reports by collecting, analyzing, and summarizing data; making recommendations.

Requirements

• Strong interpersonal and presentation skills needed to interact with external customers as well as with all levels within the company.
• Must demonstrate excellent writing skills with ability to prepare/review and/or approve technical documentation.
• Thorough knowledge and experience surrounding quality control inspection.
• Previous Medical Device experience in a quality role is preferred but not required.
• Knowledge of ISO 9001, ISO 13485 standards and/or FDA 21 CFR part 820 a plus.
• Minimum Bachelor’s degree in an Engineering or Science discipline.
• Green Belt or ASQ certification a plus.
• Proven problem-solving experience.
• Ability to work in an entrepreneurial, fast pace and rapidly evolving environment.