Summary: Develop, implement, and continuously improve a quality program that increases customer satisfaction and facilitates business success. Foster a culture of quality performance, execution, compliance, and customer satisfaction. Lead, train, and assist quality personnel to oversee quality-related activities in conjunction with manufacturing, engineering, purchasing, customer support, and other departments/functions that affect the quality of the organization's goods or services.
Essential Duties and Responsibilities:
Subject matter expert of ISO 9001 program.
Cooperates with other top management personnel in formulating and establishing company policies, operating procedures, and measures/KPIs.
Visits and confers with representatives of material and component vendors to obtain information related to supply quality, capacity of vendor to meet orders, and vendor quality standards.
Supervises Quality Assurance Department personnel which includes Quality Foreman, and Quality Inspectors
Monitors the quality of the design process.
Ensure that certifications are maintained.
Reviews customer specification requirements relative to product quality and assures compliance.
Reviews internal documentation for compliance to requirements.
Utilize Statistical Process Controls and/or sampling plans.
Maintains a failure reporting and CAPA system for internal and external issues
Active participant in the Internal Audit Program
Maintains Non-conforming Material control.
Monitors and reports on Supplier Quality issues.
Participate in ongoing process improvement activities and teams.
Knowledge of quality tools such as PDCA, FMEA, and Root Cause Analysis are required.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Provide trending analysis on quality issues and performance metrics.
Work closely with Design and Production Engineers and Operators to identify and resolve production and quality system deficiencies.
Comply with all safety requirements
Knowledgeable in data collection, measuring, analysis, improvement and control. Proficient in use of Microsoft Office Suite. Working experience with Good Manufacturing Practices, ISO 9001, and risk based quality standards. Working knowledge of manufacturing processes.
Ensure products, documentation and deliverables meet internal and external standards.
Other duties may be assigned to meet business needs.
Qualifications:
Experience in an industry with regulatory requirements and high quality standards
Demonstrated high level of competency in the application of Quality Tools, Six Sigma Programs, and Lean Thinking
Mechanical and Electrical print and specification interpretation
Ability to lead and manage hourly and salary personnel
Team oriented and customer driven
Education/Experience:
BS in Mechanical, Industrial or Quality Engineering
10 years of Quality Leadership in ISO operations that covers all aspects of design, development, qualification, fabrication, manufacturing, and aftermarket support and service
Experience with highly customized, high mix, low volume, make-to-order manufacturing.
Must have experience with ISO (such as 9001:2015) processes and procedures.
Experience in complex quality initiatives.
Knowledge of statistical analysis software programs.
Knowledge of lean manufacturing or six sigma principles a plus.
Strong verbal and written communication skills including good persuasion skills are a must.
An understanding of a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements.
Experience with SAP.
Certificates, Licenses, Registrations:
CQM - Certified Quality Manager
CQE - Certified Quality Engineer
Certified Quality Auditor
Lean Six Sigma Black/Green Belt
Language Skills:
Ability to read and understand English instructions.
Ability to speak effectively with employees of the organization.