We are seeking an experienced Quality Engineer 4 to support quality engineering activities in a high-tech electronics manufacturing environment. The ideal candidate will have strong experience in Quality Management Systems (QMS), quality audits, regulatory compliance, SMT/PCB assembly, and corrective and preventive actions.
The Quality Engineer will develop and maintain quality standards, implement inspection and testing procedures, investigate product and process issues, and ensure compliance with applicable quality and regulatory requirements. This role will work closely with engineering, production, quality program management, and customer teams to maintain product quality, improve manufacturing processes, and drive corrective actions.
Key Responsibilities
- Develop and implement standards and procedures for product inspection, testing, evaluation, and quality control.
- Establish sampling procedures and maintain methods for recording, analyzing, and reporting quality and reliability data.
- Manage nonconforming materials and develop procedures for material disposition and corrective actions.
- Direct and support quality inspection and testing activities across manufacturing operations.
- Develop quality training materials and conduct training sessions on quality control procedures.
- Collaborate with Product Engineers and Quality Program Managers on customer-related quality issues.
- Ensure the accuracy, integrity, and availability of quality data and prepare consolidated quality reports.
- Initiate corrective action requests, track progress, and ensure timely closure.
- Support the development, execution, and maintenance of internal and external quality audits.
- Develop, apply, revise, and maintain quality standards for manufacturing processes and finished products.
- Design and implement methods for evaluating product quality, process performance, and production equipment accuracy.
- Investigate quality issues, customer complaints, and returned products, and recommend corrective actions.
- Establish programs to evaluate the precision and accuracy of production, testing, and measurement equipment.
- Review and approve product, process, and equipment qualifications as applicable.
- Support regulatory compliance and coordinate with relevant regulatory bodies when required.
- Drive continuous improvement initiatives to improve product quality, process reliability, and manufacturing efficiency.
Required Qualifications & Skills
- Bachelor's degree in Engineering or a related field, or equivalent experience.
- 5+ years of Quality Engineering experience in high-tech electronics manufacturing or a related industry.
- 5 years of experience with Quality Management Systems (QMS) and quality audits.
- 5+ years of compliance experience.
- Hands-on experience with electronics manufacturing, Surface Mount Technology (SMT), or Printed Circuit Board Assembly (PCBA/PCB assembly).
- Strong knowledge of CAPA, root cause analysis, corrective action tracking, and nonconformance management.
- Experience developing and maintaining quality standards, inspection procedures, and testing methods.
- Knowledge of regulatory and safety standards and product/process qualification.
- Experience analyzing quality data, preparing reports, and maintaining quality documentation.
- Strong analytical, troubleshooting, problem-solving, and communication skills.
- Ability to collaborate effectively with production, engineering, quality, and customer-facing teams.
- Willingness to work onsite in Milpitas, CA for the duration of the contract.
Preferred Qualifications
- Knowledge of ISO 9001 and ISO 13485 quality management standards.
- Experience conducting internal and external quality audits.
- Experience with Statistical Process Control (SPC), sampling procedures, and reliability testing.
- Knowledge of FMEA, 8D, 5 Why, Fishbone analysis, and Six Sigma methodologies.
- Experience with supplier quality management and customer quality requirements.
- ASQ Certified Quality Engineer (CQE) certification or equivalent qualification.
- Experience in high-volume electronics manufacturing environments.
Benefits:
Eligible employees may enroll in and receive benefits offered by Intellectt Inc., subject to applicable plan terms, eligibility criteria, and contribution requirements.
Equal Employment Opportunity Statement
Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, or any other protected characteristic.