Quality Engineer

Job description

Function: Quality Assurance

Job: Quality Engineer

Purpose:

·        The purpose of a Quality Engineer is to ensure that products and processes meet customer expectation as defined by FEI Quality Standards, relevant industry regulations, and customer specifications.

·        Facilitate and coordinate compliance related initiative throughout the facility.

·        Facilitate continuous improvement events and projects.

Key Responsibilities:

·        CAPA Management: Lead and manage Corrective and Preventive Actions (CAPA) to resolve quality issues. Use the 8D process for evaluating and documenting non-conforming product and processes. This includes identifying root causes, implementing corrective actions, and verifying the effectiveness of these actions.

·        Data Analysis: Collect, analyze, and interpret quality data to identify trends, root causes of defects, and areas for improvement. Use statistical methods to monitor and improve product quality. Proficiency in creating software systems to report on production quality is a plus.

·        Zero Defects Quality Control: Develop and implement strategies aimed at achieving zero defects in the production process. Work closely with production teams to ensure adherence to quality standards and continuous improvement. Experience creating Poka-Yoke solutions and inspection fixtures.

·        Quality Audits: Conduct internal and supplier audits to ensure compliance to customer requirements and specifications. Develop audit reports and track the implementation of corrective actions.

·        Documentation: Maintain and update quality documentation, including control plans, inspection criteria, and standard operating procedures (SOPs). Ensure all documentation meets regulatory and company standards.

·        Training: Provide training and support to production staff on quality control procedures and best practices. Foster a culture of quality awareness and continuous improvement within the organization.

·         Compliance: Facilitate and sustain of regulatory and certification body in safety, quality, and security. 

·        Lean: Use of Lean Six Sigma principles to promote continuous improvement initiatives in operations and business aspects or operations.

·        Collaboration: Work cross-functionally with other departments, to ensure quality standards are adhered to.

Qualifications/Requirements:

·        Bachelor's degree in Electrical, Mechanical or Industrial Engineering, or Robotics or Integration Engineer with manufacturing experience.

·        Ideally, 3 to 5 years of experience in a quality engineering role within a manufacturing environment.

·        Strong knowledge of CAPA processes and methodologies.

·        Proficiency in data analysis tools and software.

·        Experience with quality management systems (QMS) and standards (AS9100, ISO9001:2015, ISO13485).

·        Knowledge of IPC-A-610, IPC-A-620, and JSTD-001.

·        Certification in Quality Engineering (CQE) or Six Sigma is a plus.

·        Experience in Lean Principles is a plus

Reports to: Quality Manager

Job Type: Full-time

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• Day shift
• Monday to Friday

Experience:

·        5 years of experience in a quality engineering role within a manufacturing environment.

Work Location: In person