Product Quality Assurance Specialist
4 weeks ago
Venture Corporation Limited, a leading global provider of technology services, products, and solutions, is seeking a highly skilled Product Quality Engineer to join our team in Milpitas, California.
Job SummaryThe Product Quality Engineer will be responsible for ensuring the quality of our products, from design to delivery, by implementing and maintaining our quality management system. This includes supporting internal audits, ensuring quality-related deliverables are met, and providing quality engineering and assurance services.
Key Responsibilities- Support the implementation and maintenance of our quality management system, including ISO 9001:2015, AS9001D, and ISO 13485:2016.
- Ensure quality-related deliverables are met as defined by the product development process and project plans.
- Provide quality engineering and assurance services to support product quality and overall system compliance.
- Identify and implement effective process control systems to support the development, qualification, and ongoing manufacturing of products to meet or exceed internal and external requirements.
- Work with manufacturing and process engineering to ensure product quality.
- Work with customer SQEs and other related engineering fields in the completion of product qualification process (PQP) and production part approval process (PPAP).
- Coordinate and manage the corrective and preventive action system (CAPA).
- Lead root cause investigations using common root cause analysis methodologies.
- Active involvement in maintaining, reviewing, and reporting quality performance data (KPIs) and opportunities for improvement for management review.
- Evaluate product and process changes to assure compliance with regulatory, corporate, customer, and third-party safety requirements.
- Participate in MRB/CPI to engage with process and yield improvement.
- Monitor RMA return rate and support FA/process improvement.
- Bachelor's degree in a technical discipline (engineering, math, science, or equivalent experience).
- At least 5 years of experience in contract manufacturing in PCBA and box build assembly.
- Extensive knowledge and certified internal auditor in ISO 9001:2015, ISO 14001:2016, ISO 13485:2016, and AS9100D.
- Familiar with DOE, FMEA, PPAP, SPC, PQP, TQM, ISO, Six Sigma.
- Knowledge of basic QA functions, including IQA, FQA, MRP, RMA, FAI, QCC, CAPA, SCAR, etc.
- Strong analytical skills and hands-on problem-solving with decision-making background.
- Strong knowledge in Microsoft Office (Word, Excel, PowerPoint, Access Database).
- Understand SMT processes and quality requirements.
- Good communication and writing skills.
- Strong knowledge of PCBA (SMT and PTH) box-build and repair (RMA) business.
- Must be familiar with medical products requirements.
- Knowledge in IPC, Bellcore, and JEDEC standards.
- Statistical process control and/or Six-Sigma capabilities.
- Must be able to work independently with minimum supervision.
- Experience in PFMEA and process control plans.
- Experience in Eight Disciplines (8D) problem-solving methodology.
- IPC-A-610 & J-STD-001 CIS or CIT certification.
- ISO 9001, ISO 13485, and AS9100 internal auditor certification.
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