Quality Engineer

South Bay Solutions • Fremont, CA

4d

About The Position

South Bay Solutions is a high-precision machine shop serving the semiconductor, medical-device, and advanced-technology hardware industries. The Quality Engineer supports and improves the quality, reliability, and consistency of manufacturing processes. The role works directly with production teams to investigate problems, implement corrective actions, and drive continuous improvement on the shop floor, while collaborating with Manufacturing, Engineering, Supply Chain, and suppliers to ensure products meet customer, regulatory, and internal quality requirements.

The position involves translating drawings and customer requirements into manufacturing and inspection requirements; developing quality plans and inspection methods; supporting new product introduction, process development, qualification, and validation; and applying statistical quality tools to identify and reduce process variation. The Quality Engineer also manages nonconformances and corrective actions, supports audits and the Quality Management System, analyzes quality data, and contributes hands-on support to production-floor troubleshooting and continuous improvement.

Schedule: 8-hour shifts, Monday to Friday. South Bay Solutions does not offer visa sponsorship.

Requirements

• 2–5 years of Quality Engineering experience in a manufacturing environment.
• Hands-on experience working with manufacturing and production teams in a shop-floor environment.
• Strong understanding of manufacturing processes, inspection methods, and quality control principles.
• Ability to read and interpret engineering drawings, specifications, and GD&T.
• Working knowledge of ISO 9001 and/or ISO 13485 quality management systems.
• Experience with quality tools including PFMEA, Control Plans, Process Flow Diagrams, 8D, 5-Why, Fishbone/Cause-and-Effect Analysis, SPC, MSA and Gage R&R, Process Capability Studies, PPAP, and corrective and preventive actions.
• Strong problem-solving and analytical skills, including the ability to identify root causes and implement practical solutions.
• Excellent written and verbal communication skills.
• Strong documentation and organizational skills.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.
• Ability to work independently and collaborate effectively with Production, Engineering, Supply Chain, and suppliers.
• Bachelor’s degree in Mechanical Engineering, Industrial Engineering, Manufacturing Engineering, Quality Engineering, or a related technical field; equivalent manufacturing quality experience will also be considered.

Nice To Haves

• Experience with ERP/MRP systems.
• Experience with CMM, dimensional inspection, or advanced metrology.
• Experience with manufacturing process validation, including IQ/OQ/PQ.
• Knowledge of quality risk management and structured problem-solving methodologies.
• Six Sigma, CQE, CSSGB, or another quality-related certification.

Responsibilities

• Review engineering drawings, specifications, and customer requirements and translate them into manufacturing and inspection requirements.
• Develop and maintain Control Plans, PFMEAs, Process Flow Diagrams, inspection plans, and work instructions.
• Support new product introduction, process development, and manufacturing qualification activities.
• Develop inspection methods, sampling plans, and measurement strategies.
• Perform Gage R&R, MSA, capability studies, SPC, and process analysis to identify and reduce process variation.
• Work with production teams to identify quality issues, troubleshoot manufacturing problems, and prevent recurring defects.
• Lead root-cause investigations using methods such as 5-Why, Fishbone, 8D, and corrective action processes.
• Manage internal and supplier nonconformances and support timely corrective-action implementation and closure.
• Participate in MRB activities, including investigation, documentation, disposition, and follow-up of nonconforming material.
• Support customer complaints, returns, RMAs, and quality investigations.
• Develop and implement corrective and preventive actions and verify their effectiveness.
• Support supplier quality activities, including audits, incoming inspection requirements, supplier corrective actions, and supplier performance monitoring.
• Assist with IQ/OQ/PQ and process validation for manufacturing processes and equipment.
• Support maintenance and continuous improvement of the Quality Management System.
• Participate in internal, customer, supplier, and certification audits.
• Maintain quality records, inspection documentation, traceability records, and other quality documentation.
• Support engineering and manufacturing change control and ensure appropriate quality reviews are completed.
• Analyze quality data such as scrap, rework, defects, nonconformances, returns, and process capability, and communicate trends to management.
• Lead or participate in continuous improvement initiatives focused on defect reduction, process capability, scrap reduction, and manufacturing efficiency.
• Support Lean Manufacturing, 5S, and continuous improvement activities.
• Work with Engineering and Manufacturing on design-for-manufacturability reviews, process improvements, tooling, fixtures, and measurement methods.
• Provide hands-on quality support on the production floor and assist with troubleshooting as needed.
• Perform other quality-related responsibilities as assigned.

Benefits

• Health insurance (medical, dental, and vision) paid 100% for employees.
• Life insurance policy.
• Safe Harbor 401(k) plan.
• 401(k) match.
• Paid time off, including vacation, sick leave, holidays, and a floating holiday.
• Referral program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level