Quality Engineer

Summary:

Under the minimal supervision of the Quality Manager. Provides technical support for the development and implementation of ISO 9000 Quality Management systems in a Lean Continuous Process Improvement environment. Also, to provide quality engineering support to all sales, engineering, procurement, and production operations.

JOB DUTIES: Include but are not limited to the following:

• Assists Quality Manager in maintaining the Quality Management System and performs the duties of the Quality Manager in his/her absence

• Proven experience in maintaining ISO 9000 certification: auditing, reporting KPIs, documentation generation and maintenance

• Provides technical Quality oversight of contract review, design review, work order review, vendor qualification and production audit for customer contracts/specifications, design documents, purchase orders, and other documents to ensure that customer and regulatory requirements are met

• Serves as a member of the MRB; reviews defective material; develops and implements methods and procedures for disposition; determines additional process steps required; updates inspection and engineering documentation; trains personnel; and devises methods to assess cost and responsibility

• Application experience of quality tools such as FMEA, PMP, SPC, 8D methodology, etc.

• Sponsors for regulatory, partnership, or customer audits; participates in and leads internal and external audits

• Plans and directs activities concerned with development, application, and maintenance of quality standards for processes, materials, and products

• Troubleshoot technical product issues and work with engineering team for resolution

• Devises sampling procedures including forms and instructions for recording, evaluating, and reporting the data

• Establishes programs to evaluate precision and accuracy of production equipment and testing, measurement, and analytical equipment and facilities; evaluates production capabilities using statistical analysis (Process Capability Analysis) and recommend improvements:

• Lead and facilitate cross functional team in creation and of FMEA and PFMEA

• Provides quality engineering leadership to supplier development and sourcing activities and performs annual supplier evaluations

• Supports Continuous Process Improvement and Kaizen activities where appropriate and serves as a key member of project teams involved in new product introduction

• Directs the Measuring & Test Equipment program

• Develop and maintain internal quality system, procedures, work instructions and workmanship standards

Requirements

MINIMUM EXPERIENCE:

• Bachelor’s degree in engineering or, a related technical field, or equivalent
• At least 3 years of work experience in quality assurance

PREFERRED EXPERIENCE:

• 5 years’ experience in quality engineering role or technical role in electronic manufacturing environment
• Strong statistical analysis knowledge and application
• Process audit methodology, reporting, CAPA implementation
• ISO/TL 9000 maintenance and support

SOFT SKILLS:

• Strong interpersonal, analytical, organizational and follow-up skills

• Excellent leadership qualities

• Strong communication skills (verbal and written)

• Excellent time management skills with a proven ability to meet deadlines.

• Excellent attention to detail.

• Proficient with Microsoft Office Suite or related software.

You should be proficient in:

• Statistical process control (SPC)
• Process Failure Mode and Effects Analysis (PFMEA)
• Kaizen
• Lean Manufacturing Principles
• Root Cause Analysis
• 8D
• Auditing
• ISO 9000 Standards
• ISO 9001
• Manufacturing Quality
• Process Capability Analysis
• Quality Assurance
• Quality Management Systems (QMS)
• Regulatory Compliance
• Supplier Quality Management
• Documentation Control