Manufacturing Quality Engineer

Brief Description The Manufacturing Quality Engineer (MQE) 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.

Major Responsibilities

• Leads/Drives corrective and preventive actions, and effectiveness verification activities for product quality issues.

• Applies knowledge of metrology and GD&T to develop inspection and test methods for a wide array of products and processes.

• Researches novel metrology approaches where necessary to support new or existing processes.

• Develops control plans and sampling plans for the purposes of process control or validation for attribute, and variable data, for lot based and sequential sampling methods, based upon process data and understanding of manufacturing processes.

• Understands APQP and PPAP processes and can apply related tools to complete or lead teams in product launch activities.

• Understands and applies statistical concepts including but not limited to:

• Utilization of hypothesis testing, capability analysis, and other methods based on use of normal and non-normal data distributions where appropriate.

• Control charting methodologies for various types of data, manufacturing processes, and desired controls.

• Confidence intervals and their relation to sampling and appropriate application for given risk levels.

• Practical application of ANOVA methods for Gage R&R and DoE analysis.

• Works closely with production line to ensure all necessary controls are enforced to be compliant with ISO 13485 and FDA QSR requirements, and resources are available to support efficient production.

• Develops/Uses Key Process Indicators and statistical methods to determine process effectiveness, identify areas for improvement, best practices, and lead teams in driving continuous quality improvement.

• Prepares reports by collecting, summarizing data and performs analysis of reports for production, quality inspection, and customer feedback data to identify trends and recommend updates and changes to the Quality System when necessary.

• Ensures that quality reporting and records related to these functions (e.g. incoming and in-process quality trends; returns analysis, complaint investigation, corrective action activity, etc.) are clearly documented and maintained.

• May conduct internal audits and other quality system functions as assigned.

• Establish and participate in supplier qualification/development activities.

• Contributes to other team efforts to by accomplishing any related tasks as needed to meet business goals.

Skills And Abilities

• 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.
• Ability to work in an entrepreneurial, fast-pace and rapidly evolving environment.

Requirements

• Previous Medical Device experience in a quality role is preferred but not required.
• Thorough knowledge of ISO 9001 and ISO 13485 standards and FDA 21 CFR part 820.
• Minimum Bachelor’s Degree in an Engineering or Science discipline.
• Green Belt or ASQ certification a plus.
• Proven problem-solving experience.