Job Description

Job Summary & Essential Functions

Establishes and plans quality requirements from quotation through program start and implements and monitors quality processes and methods to assure effective control of the quality of customer products and solutions. Leads quality improvements efforts through identifying, correcting, and preventing causes of quality problems. Develops and directs activities to assure that the company quality policy and the quality management system are followed and are effective. 

• Ensure that all contractual and regulatory quality requirements are defined and communicated for assigned customers and programs
• Provide effective and timely direction and support to receiving, in-process, and final product quality control, monitoring, and surveillance processes 
• Facilitate and lead teams and efforts to investigate, identify and address the root cause of product and process quality issues 
• Collaborate with sales, purchasing, production, quoting and program management to establish plans and procedures for meeting customer quality requirements
• Interface with suppliers and internal teams to identify, correct and prevent problems with purchased material
• Assist in defining and monitoring the quality management system and in developing an organizational culture that stresses quality-centric processes, decisions, and behavior. 
• Communicate with and provide interface to customers on field quality issues and problem resolution
• Assist in monitoring processes and activities to ensure compliance with company guidelines, policies, and procedures
• Document and communicate observed or potential quality issues to management.
• Develop, maintain and support quality standards and compliance activities for manufacturing and operations
• Identify, evaluate, and report analysis results of quality data
• Create, write, release, and update quality assurance procedures and instructions
• Develop, conduct and facilitate training to implement and support the quality management system
• Provide leadership and direction to develop and implement supplier quality requirements
• Develop, facilitate, and execute process validation efforts
• Facilitate and conduct internal and supplier quality audits
• Develop quality plans and lead projects for implementing quality related changes
• Support and facilitate efforts for maintaining and improving the Quality Management System
• Identify opportunities and support efforts for integrating risk management methods into the QMS
• Facilitate and provide leadership in maintaining and improving quality commitment and culture

Knowledge, Skills, & Abilities

• Knowledge of electromechanical systems
• Knowledge of machine shop operations
• Advanced knowledge of SMT, selective soldering, and wave soldering operations
• Knowledge of SPC, TQM, Lean Manufacturing, ISO standards, and IPC Standards
• Advanced ability to read and interpret mechanical engineering drawings, production drawings, wiring drawings, and electronic schematic diagrams, and routers
• Advanced knowledge and use of applicable workmanship or other acceptability standards
• Ability to read measurement and calibration tools and instruments
• Technical writing and documentation skills
• Intermediate knowledge of GD&T
• Ability to develop and write process instructions and procedures
• Knowledge of Measurement System Analysis (MSA) and Gage R&R methods
• Ability to develop and execute process validation plans and protocols (IQ/OQ/PQ) and report results
• Ability to develop Quality training materials and conduct training
• Ability to employ statistical/quantitative methods and use common software applications such as Minitab
• Ability to use and facilitate teams in process improvements/six sigma methods
• Knowledge of risk management techniques and ability to facilitate PFMEA’s
• Analytical, investigative, and critical thinking skills
• Ability to perform root cause analysis
• Intermediate level in MS Office (Word, Excel, and Outlook)
• Ability to guide, coach, and mentor teams
• Ability to effectively communicate in all forms with others inside and outside the organization
• Ability to resolve time-critical quality issues diplomatically
• Ability to work with a high level of accuracy and attention to detail to produce quality results
• Ability to plan, resolve problems effectively, and establish priorities
• Ability to multitask efficiently and adapt within a rapidly changing environment

Required Experience & Education 

• Bachelor's degree in engineering or technical equivalent with a minimum of five years prior work experience; relevant certification or associate degree with a minimum of six years of relevant work experience; or high school diploma with a minimum of ten years of relevant work experience required
• Previous experience in a manufacturing of electromechanical products or printed circuit assemblies required
• Previous experience with regulated quality systems including ISO 9001 or ISO 13485 required
• Previous experience performing data analysis and trending required
• Previous experience in project management