Quality/Manufacturing Engineer

Job Summary:

This is a hybrid QE/ME role reporting to the Quality Assurance Manager. This engineer would be responsible for designing, implementing and reviewing the procedures and equipment involved in the manufacturing process as well as ensuring the quality of products through the application of standard QA practices and adherence to quality system as directed by ISO 9001:2015. The ideal candidate will possess a bachelor’s degree in engineering. Typical responsibilities for this position would include planning and coordination of manufacturing/quality projects and activities to ensure the quality and reliability of products. Assure the timely, accurate evaluation of manufacturing performance and compliance with safety and regulatory requirements. Develop, execute and/or monitor quality plans, work instructions and quality engineering tasks, as well as manufacturing process validations and controls to ensure compliance with established requirements and regulatory expectations. Provide support for released products, evaluate product field performance and reliability, recommend corrective actions and plan for continuous improvement duties as assigned. Promotion of overall QMS awareness and enforcement.

Job Duties:

• Propose and Implement process changes to eliminate waste, improve productivity and overall effectiveness during Manufacturing process.
• Develop and initiate standards and methods for inspection, testing, and evaluation utilizing knowledge in engineering fields such as electrical and mechanical.
• Determine critical dimensions and devise control plans, sampling plan and procedures.
• Design and develop forms and instructions for recording, evaluating, and reporting quality and reliability data.
• Design custom tooling for use in the production assembly process.
• Participate and lead continuous improvement projects.
• Participate in the Design Control Process, review design inputs (specifications) and design outputs (reports, prints, etc.) to assure that appropriate design requirements are specified and to evaluate/confirm quality requirements prior to successful design transfer.
• Review, approve and develop (as needed) product verification plans and respective test methods through the development of a Protocol/Final Report based validation process.
• Participate in Engineering Change Notification (ECN) process to review and approve engineering change requests.
• Participate in Material Review Board (MRB) to review and disposition nonconformities and to work with Supplier Quality Engineering to coordinate supplier corrective actions.
• Work with Manufacturing to coordinate and monitor production processes to ensure compliance to applicable regulatory requirements, to ensure that safe and effective products are produced and to identify continuous improvement opportunities.
• Provide validation support by applying manufacturing quality tools including, but not limited to: FMEA, control plans, process verification/validation plans, protocol and final report development, Cpk, SPC, DOE and process data analysis.
• Participate in complaint investigations, failure analysis of returned products, and issues resulting in a stop ship/stop production; document findings, provide reports and analysis, & document health risk assessment.
• Routine management and execution of the Custom Product process.
• Author documents and procedures as necessary to ensure continual departmental compliance.
• Performs other duties as assigned.

Work Experience Requirements:

• 3+ years directly related experience in electro-mechanical assembly and component design. Strong manufacturing and Lean Principal background. Effective verbal and written communication skills.

Skills & Education Required:

• Knowledge of drawing and schematic interpretation, product models, geometric dimensioning and tolerance establishment.
• Proficient using SolidWorks software.
• Read, analyze, and interpret technical drawings, procedures, and governmental regulations.
• At least 1 year of custom tooling or fixture design experience.
• Write technical reports, business correspondence, technical procedures, as well as administrative procedures.
• Determine and develop an approach to a wide range of issues and problems. Solutions must be thorough, practical, and consistent with organization objectives.
• Sampling plans and techniques.
• Inspection plan creation.
• Knowledge of injection molding process.
• PCBA, wire harness, electro-mechanical, machining, casting and sheet metal fabrication, assembly and inspection process knowledge.
• Experience in use of statistical tools and techniques for quality management.
• ISO 9001-2015 Quality Management System.
• Experience participating in MRB activities.
• Office tools and equipment including Microsoft Office and ERP systems.
• Strong written and oral communications skills.
• Ability to work cooperatively and productively with other employees and suppliers.
• A bachelor’s degree in an Engineering Field

• Master’s degree preferred.