Quality Engineer

Quality Engineer

LOCATION: 101 COLUMBUS STREET, AUBURN, NEW YORK 13021

JOB SUMMARY:

The Quality Engineer assures products, processes, and quality records conform to quality standards and establish compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by safely meeting business needs. Lead on-time completion of Quality Assurance (QA) engineering deliverables.

ESSENTIAL JOB FUNCTIONS:

25%

Modify testing and methods of control to ensure cost effective product quality that meets or exceeds the products quality specifications and standards within the regulatory restraints under which the company operates including but not limited to:

• Modifying methods of measurement and inspection work instructions for existing products in the most accurate, cost effective, and least labor-intensive manner, while still ensuring product quality.
• Providing statistical information for quality improvement and cost savings through data acquisition, analysis, and periodic evaluations.
• Investigating quality related problems with products and processes, working inter-departmentally, to determine cause, recommend corrective action, and implement necessary modifications to the QMS to establish and improve control.
• Performing internal quality audits as assigned, reporting results of the audit, and recommending corrective action necessary.
• Programming CMM – Zeiss Calypso software.

50%

Assist manufacturing departments with process validation of customer projects including, but not limited to:

• Planning and performing Gage R&R, DOE, IQ, OQ, PQ processes.
• Performing capability studies, analyzing data, and make recommendations to achieve acceptable Cpk.
• Acting as QA representative for sampling projects which require initial measuring to evaluate if sample should continue, or if changes must be made to tool/process.
• Providing necessary data and dimensional measurements to verify tool and process modifications yielded desired results.
• Presenting the results to the customer.

15%

Assist manufacturing departments with production and analysis of on-going customer projects including, but not limited to:

• Making day to day decisions on product acceptability acting as the customer representative.
• Creating or eliminating deviations from product specifications based on necessity.
• Providing input on quality to product development team.
• Recommending production improvements through data driven evaluations and by applying continuous improvement principles and techniques to critical areas of production.
• Responding to customer complaints and corrective actions, interfacing with the customer and departments internally to rectify issues, leading to continuous improvement of product quality.

10%

Administer the company’s on-line Statistical Process Control (SPC) system with duties including, but not limited to:

• Creating standards for each part critical to quality (CTQ) feature within the software program.
• Designing data entry templates for each part.
• Troubleshooting system any errors that may occur, monitoring database to isolate problems and locate trends then report to appropriate departments for action.
• Creating statistical charts and reports as necessary for process and/or tool adjustments to improve capability.

KNOWLEDGE, SKILLS, & ABILITIES:

• Working experience with process validation (DOE, IQ, OQ, PQ) and SPC (minitab).
• Accountable for decision making and oversight within the QMS, including CAPA (Corrective and Preventative Action) systems.
• Collaborating and influencing key stakeholders to develop and maintain QA procedures, forms, and system related documentation.
• Maintain quality system related records, ensuring accuracy and compliance to customer requirements.
• Make decisions regarding product acceptability, based on associated levels of confidence and risk factor.
• QAE is to function as a representative of the customer and act accordingly.
• Devise and implement various methods and procedures for inspecting, testing, and evaluating the precision, reliability, and accuracy of products and processes.
• Contribute to the overall success of the company by performing all assigned duties in a professional, timely, and accurate manner.