Quality Engineer

SUMMARY: The Quality Assurance Engineer will be responsible for variety of Quality Assurance activities related to coated product and process improvements. Specific functional areas include, but are not limited to design and execution of DOEs, qualifications and validations. The QE will also be responsible for investigation and corrective and preventive action determination of the defective product, identified as such via external and internal means. This job reports directly to the Director of Quality Assurance. RESPONSIBILITIES:  In conjunction with Process Engineering and Operations; manage the CAPA/NCMR program by performing root cause analysis, recommending, writing and implementing corrective/preventive action and perform training.  In conjunction with Engineering develop and conduct process validation (IQ/OQ/PQ), risk analysis (PFMEA), experimental design (DOE) and Test Method Validation along with the PCCI Engineering team.  Responsible for assessing and developing inspection methods, test methods and tools for Operations.  In conjunction with Customer Service, review customer prints for determining measurements methods and quality plans.  Responsible for managing the company calibration program for metrology and process equipment.  Responsible for writing and revising SOPs, work instructions and Quality Management Systems documentations as necessary. ESSENTIAL QUALIFICATIONS:  Experience and Education:  Bachelor’s Degree in Manufacturing Engineering or equivalent preferred.  Five years of Quality Engineering experience within an ISO 13485 registered organization is desired.  Experience within manufacturing setting is preferred.  Excellent verbal and written communication skills are necessary.  Experience with quality engineering tools and principles including process validation (IQ/OO/PQ), risk analysis (PFMEA), experimental design (DOE) and Test Method Validation.  Experience with supporting a manufacturing facility is a must.  Experience in PPAP (Production Parts Approval Process) is preferred.  Sound knowledge of SPC and statistical tools is preferred  Experience with gaging methodologies  Green Belt/Black Belt Certification and/ or ASQ Certification is highly desired.  Proficiency with MS Office products, ERP manufacturing software, and all relevant software tools applicable to managing and supporting a Quality function.  Ability to read and interpret documents such as job travelers, blueprints, sketches, diagram, special quality plans and other procedural materials and documents.  A capacity for attention to detail and exact and precise mentality.  Ability to use measuring devices and metrology (laser micrometers, calipers, etc.)  Fundamental geometry, fractions, percentages, ratios and measurements.  Physical Demands: While performing the duties of this job, the employee is regularly required to use hands and fingers. Must be able to speak and hear. The employee is required to walk, reach with hands and arms and occasionally sit, stoop and crouch. Requires mental and visual attention to detail as well as hand coordination. Occasionally lifting or moving average weight material. Please be aware that flow of work and character of duties involve normal mental and visual attention along with manual coordination or part‐time normal and part‐time concentrated attention and coordination.

 Language Skills: Employee must be able to read and interpret documents written in English. Employee must be able to have good communication with fellow employees, supervisors and management. Personal Protection Equipment  Following items are available as needed:  Safety glasses are required in designated areas.