Quality Engineer

Synapse-ITS; Town of Texas (WI); On-site; USD 70,000 - 95,000; Full time

Job summary

Synapse-ITS is seeking a Quality Engineer to support ISO 9000 QMS in a Lean Continuous Process Improvement environment. You will provide technical quality engineering support across sales, engineering, procurement, and production, ensuring regulatory and customer requirements are met.

The role includes maintaining the Quality Management System, auditing, KPI reporting, MRB participation, and leading cross-functional teams on FMEA/PFMEA, CAPA, and process improvement initiatives.

Qualifications

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

Responsibilities

• Maintain and support ISO 9000 Quality Management System; audit, report KPIs, and document control.
• Provide quality oversight of contract, design, and production reviews to meet customer and regulatory requirements.
• Lead MRB activities, oversee nonconforming material disposition and process improvements.
• Facilitate cross-functional teams in FMEA/PFMEA; act as QA liaison in supplier and internal audits.
• Develop sampling procedures, measurement systems analysis, and capability studies.

Skills

Quality Assurance

Statistical Analysis

Auditing

Kaizen

Lean Manufacturing

Process Improvement

Documentation

QMS

Root Cause Analysis

8D

Leadership

Communication

Education

Bachelor’s degree in engineering or related technical field

Tools

SPC

PFMEA

ISO 9000/9001

Quality Management Systems (QMS)

Job description

Job Description

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