Bachelor's in Engineering, or related discipline
One year work experience or a Master's Degree in lieu of experience
Corrective Actions / Preventive Actions Management
Knowledge of statistical problem solving methodology (Six Sigma preferred)
Process Documentation
Process Control Plans
PFMEA
PPAP's
Installation Qualification, Operational Qualification, Production Qualification
GR&R;'s & Capability Studies
Previous experience within ISO 9001 / 13485 quality management system a plus
Understanding of IPC-A-610 / IPC-A- 620 a plus
Experience with Verification and Validation activities throughout the New Product Introduction process a plus
Oversee inspection activities and personnel performing them
Oversee Manufacturing Quality Engineers and tasks they are performing
Interpret blueprint drawings, evaluate tolerances
Lead the continuous improvement activities in all areas of manufacturing
Play a key role in new product transfer into manufacturing from the quality side
Oversee corrective and preventive action investigations
Develop quality assurance plans or process control procedures that will ensure that production of finished products meets quality specifications and standards
Develop, implement and audit control plans, standards and acceptance criteria, and procedures / work instructions
Establish and participate in supplier qualification / development activities to ensure that products meet design and manufacturing requirements as part of the Supplier Quality program.
Determine process capabilities and identify improvement opportunities. Develop and implement Poka-Yoke (error proofing) methodology throughout the facility. Use Six Sigma methodology and tools to solve complex problems. Apply the lean manufacturing tools as described in the Lean System.
Lead / support cross-functional teams in the execution and reporting of quality improvement projects with a focus on overall process improvements, scrap reduction and supplier quality improvement.
Perform product / process analysis for cost reductions, quality / efficiency improvements
Evaluate process data output to determine process control limits. Utilize tools such as PFMEA, 6 sigma, Lean, and equivalent statistical techniques
Devise sampling procedures and design / develop forms and instructions for recording, evaluating, and reporting quality and reliability data
Interface with suppliers and customers to solve quality problems and improve relationships
Perform duties as assigned