Quality Engineer

About the Role

The Quality Engineer is responsible for understanding customer quality-related requirements, driving internal efforts for root cause analysis and quality improvement, and supporting high standards of precision and quality 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 the production line to ensure all necessary controls are enforced to comply with ISO 13485 and FDA QSR requirements.
• Ensure quality reporting (e.g., incoming and in-process quality trends, returns analysis, categorization, and corrective action activity) is maintained and documented with the assigned team.
• Perform analysis of reports and production data to identify trends and recommend updates to the Quality System Regulations, Standards, and/or guideline procedures when necessary.
• Determine quality improvement parameters by identifying statistical methods relevant to manufacturing processes.
• Establish statistical confidence by identifying sample size and acceptable error, and determining levels of confidence.
• Develop sampling plans by applying attribute, variable, and sequential sampling methods.
• Maintain statistical process controls by applying demerit/unit, zone charting, and x² charts for distributions, and individual-median/range for multi-stream processes.
• Analyze data by completing hypothesis, normal distribution, and process capability analysis tests.
• Prepare reports by collecting, analyzing, and summarizing data, and making recommendations.
• Contribute to team effort by accomplishing related results as needed.

Requirements

• Strong interpersonal and presentation skills to interact with external customers and all levels within the company.
• Excellent writing skills with the ability to prepare, review, and/or approve technical documentation.
• Thorough knowledge and experience in 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 is a plus.
• Minimum Bachelor’s degree in an Engineering or Science discipline.
• Green Belt or ASQ certification is a plus.
• Proven problem-solving experience.
• Ability to work in an entrepreneurial, fast-paced, and rapidly evolving environment.