Quality Engineer II / III

Job Description

Job DescriptionSalary:

Summary

The Quality Engineer II / III is responsible for sustaining and improving processes, product, and component performance; developing quality plans and managing supply base performance. Individual will provide support in procedural development and change order analysis for Mack Technologies Florida, Inc. Reports to the Quality Director.

Essential Duties and Responsibilities

• Approve and verify production circuit card and full system assembly inspection processes.
• Lead quality, engineering, and operations teams to generate effective and verifiable corrective and preventative action activities using CAPA, 8D and 5-Why methodologies for internal and external issues.
• Support incoming inspection as necessary to ensure component/supplier compliance and acceptance into inventory.
• Maintain performance reporting and analysis for internal quality metrics (DPMO, first pass yield, etc.) based on internal and customer quality data.
• Analyze process, product, and component performances to identify continuous improvement opportunities.
• Develop and manage customer specific Quality Plans.
• Provide weekly Management level reports and analysis on customer and process level quality data.
• Act as the technical team leader while interfacing with customers and suppliers on product performance.
• Provide technical assistance on customer product specifications such as labels, quality goals, assembly requirements and product performance criteria.
• Implement statistical process controls.
• Establish and monitor internal controls consistent with ISO13485/9001, AS9100 and customer requirements.
  
• Provide quality support to the product processes and operators/technicians that utilize them.
• Provide procedural /system training to QA Technicians, Operations and entry level Engineers.
• Participate in quality teams in an effort to drive high product quality and continuous improvement and increased customer satisfaction.
• Manage, analyze and publish Quality Assurance Performance Reports for assigned projects including process yields, defect/root-cause Pareto analyses and associated corrective actions.
• Review quality and product data to ensure conformance to specifications.
• Perform Internal Quality Audits and prepare for external audits.
• Generate procedures, process alerts, deviations, purges and other process documentation.
• Participate in MRB review and disposition process.
• Recommending DFM or DFT analysis for quality improvement and cost reduction.
• Facilitate ECO implementation providing analysis, approval, and verification.
• Provide some New Production Introduction (NPI) support to the product team, suppliers and customers.
• Occasional travel between Mack, customer, or supplier facilities.
• Maintain ESD integrity within production environment.
• Responsible for the cleanliness of work area and surrounding work space.
• Responsible for the accuracy of work-in-process.
• Provide training to technicians and operators for system and procedural functions.
• Participate in additional training as required.
• Other responsibilities as directed and necessary for the business.

Qualifications

• Bachelors in Electrical, Mechanical or Industrial Engineering; 7 + years of experience in quality, process, and/or supplier engineering and 5 + years of experience working within an ISO 9001 or similar manufacturing environment.
  
• Must have strong hands-on RCA background (will be asked to demonstrate during interview process).
• ASQ CQE or other quality related certification a plus.
• Six sigma green or black belt desirable.
• ISO auditor certification desirable.
• GMP/QSR/ISO13485 quality system knowledge a plus.
• Experience in medical or military manufacturing a plus.
• Baldridge background a plus.
• Knowledge of statistics and statistical methods.
• Knowledge of medium to high volume system level, assembly, and/or SMT manufacturing environment including electrical, mechanical, and/or PCA components.
• Understanding of basic electro-mechanical tools (multi-meters, calipers, etc.) and basic hand tools (wrench, torque drivers etc.).
• Ability to interpret detailed drawings, schematics and diagrams.
• Strong problem solving, mathematical and workstation skills.
• Excellent organizational, written and verbal communication skills are required.
• Strong computer skills with Excel, database and data analysis experience.
• Self-motivated, ability to work independently and quickly with a high degree of accuracy.
• Ability to act as the Customer Technical Team Leader with minimal direction.
• Ability to work and communicate effectively as a team member.
• Willingness to work flexible hours as necessary.
• US Person as defined in 22 CRF Part 120.15 (U.S. citizens, lawful permanent residents, refugees and those given asylum in the United States, and temporary residents granted amnesty) since work includes ITAR controlled technical data.