Sr Quality Engineer

2 weeks ago

Mt Pleasant, United States Intervala, LLC Full time

Job DescriptionJob 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 a related technical field

Minimum of 10 years of progressive relevant job experience

Previous experience in a manufacturing of electromechanical products or printed circuit assemblies

Previous experience with regulated quality systems including ISO 9001 or ISO 13485

Previous experience performing data analysis and trending

Previous experience in project management

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