Manufacturing Quality Engineer

Venture Corporation Limited/VM Services, Inc; Milpitas (CA); On-site; USD 95,000 - 125,000; Full time

Job summary

Venture Corporation Limited/VM Services, Inc. is seeking a Quality Assurance Engineer to support ISO audits and ensure product quality across PCBA and box-build assemblies. You will implement process controls and lead CAPA activities to maintain regulatory and customer requirements.

The role requires deep knowledge of QA methodologies, DOE/FMEA, and Six Sigma, with strong analytical and communication skills in a highly regulated environment.

Qualifications

• Bachelor’s Degree in 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, ISO13485:2016 and AS9100D.
• Familiar with DOE, FMEA, PPAP, SPC, PQP, TQM, ISO, Six Sigma.
• Knowledge of IQA, FQA, MRP, RMA, FAI, QCC, CAPA, SCAR.
• Strong analytical skill and hands-on problem solver with decision making background.
• Strong MS Office skills (Word, Excel, PowerPoint, Access).
• Understand SMT processes and quality requirements.
• Experience with PCBA (SMT and PTH) Box-Build and repair (RMA).
• Must be familiar with medical products requirements.
• Knowledge in IPC, Bellcore, and JEDEC standards.

Responsibilities

• Support ISO 9001:2015, AS9001D, ISO 13485:2016 internal audit and implementation.
• Ensure quality related deliverables are met as defined by the product development process and project plans.
• Provide Quality Engineering and Assurance Services and Technical Expertise to support product quality and system compliance.
• Identify and implement effective process control systems for development, qualification, and manufacturing.
• Coordinate CAPA system and lead root cause investigations using 5 Whys, Ishikawa, Pareto.

Skills

Quality systems

ISO 9001

Six Sigma

CAPA

Root Cause Analysis

QA analytics

MS Office

Education

Bachelor's Degree in Engineering/Science

Tools

Excel

Access Database

Job description

• Support ISO 9001:2015, AS9001D, ISO 13485:2016 internal audit and implementation.
• Ensure quality related deliverables are met as defined by the product development process and project plans.
• Provide Quality Engineering and Assurance Services and Technical Expertise to support product quality and overall system compliance.
• Identify and implement effective process control systems to support the development, qualification, and on-going 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 efforts using common Root Cause Analysis Methodologies (5 Whys, Fishbone Ishikawa, Pareto Charts, etc.)
• 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 3rd party safety requirements (UL, Intertek, CCC, Etc.).
• Participate in MRB/CPI to engage with process and yield improvement
• Monitor RMA return rate and support FA / Process improvement
• Ensuring that the quality management system conforms to the requirements of International Standard.
• Ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

Job Requirements:

• Bachelor’s Degree in 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, ISO13485:2016 and AS9100D
• Familiar with DOE, FMEA, PPAP, SPC, PQP, TQM, ISO, Six Sigma
• Knowledge of the basic QA functions i.e. IQA, FQA, MRP, RMA, FAI, QCC, CAPA, SCAR, etc.
• Strong analytical skill and hands-on problem solver 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 a must.
• 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.

Preferred

• 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
• ISO9001, ISO13485 and AS9100 Internal Auditor Certification

** This role is not eligible for relocation or remote work **