Quality Engineer

The Quality Engineer is responsible for understanding customer quality related requirements, driving internal efforts for root cause and quality improvement, while supporting our high standards of precision and quality products in the inspection of medical parts.

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.
• Contributes to team effort by accomplishing related results as needed.
• 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