Quality Engineer
southbaysolutions
- Fremont, United States
- On-site
- Mid Level
- 2+ years
- Bachelor's degree
- Posted
Skills
Required
- manufacturing processes
- GD&T
- ISO
- ISO 13485
- quality management systems
- Process Flow Diagrams 8D
- 5-Why
- Fishbone/Cause-and-Effect Analysis
- SPC
Preferred
- ERP/MRP systems
- manufacturing process validation
- IQ/OQ/PQ
- Sigma
- CQE
- CSSGB
We are seeking a Quality Engineer with hands-on manufacturing experience to support and improve the quality, reliability, and consistency of our manufacturing processes.
About southbaysolutions
- Us South Bay Solutions is a high-precision machine shop, making parts for semiconductor, medical devices, and advanced tech hardware.
- Our tolerances are measured in microns, our equipment is top-of-the-line, and our team is passionate about quality craftsmanship.
Responsibilities
- This role is ideal for a quality professional who enjoys working directly with production teams, investigating problems, implementing corrective actions, and driving continuous improvement on the shop floor.
- The Quality Engineer will work closely with Manufacturing, Engineering, Supply Chain, and suppliers to ensure products meet customer, regulatory, and internal quality requirements.
- The successful candidate will have a strong understanding of manufacturing processes, engineering drawings, quality systems, root-cause analysis, and statistical quality tools.
- Schedule 8 hour shift Monday to Friday Key Responsibilities Review engineering drawings, specifications, and customer requirements and ensure they are properly translated 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 appropriate 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 directly with production teams to identify quality issues, troubleshoot manufacturing problems, and prevent recurring defects.
- Lead root-cause investigations using structured problem-solving methods such as 5-Why, Fishbone, 8D, and corrective action processes.
- Manage internal and supplier nonconformances and support timely implementation and closure of corrective actions.
- Participate in MRB activities, including investigation, documentation, disposition, and follow-up of nonconforming material.
- Support customer complaints, returns, RMAs, and quality-related investigations.
- Develop and implement corrective and preventive actions and verify their effectiveness.
- Support supplier quality activities, including supplier audits, incoming inspection requirements, supplier corrective actions, and supplier performance monitoring.
- Assist with IQ/OQ/PQ and process validation activities for manufacturing processes and equipment.
- Support the maintenance and continuous improvement of the Quality Management System.
- Participate in internal, customer, supplier, and certification audits.
- Maintain accurate quality records, inspection documentation, traceability records, and other quality-related documentation.
- Support engineering and manufacturing change-control activities and ensure appropriate quality reviews are completed.
- Analyze quality data, including 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.
Requirements
- & Experience 2–5 years of experience in Quality Engineering within 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.
- PFMEA Control Plans Process Flow Diagrams 8D 5-Why Fishbone/Cause-and-Effect Analysis SPC MSA and Gage R&R Process Capability Studies PPAP Corrective and Preventive Actions Strong problem-solving and analytical skills with 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 and work effectively in a fast-paced manufacturing environment.
- Ability to work independently while also collaborating effectively with Production, Engineering, Supply Chain, and suppliers.
- & Preferred Experience 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.
- Knowledge of quality risk management and structured problem-solving methodologies.
Preferred
- Experience with ERP/MRP systems.
- Experience with CMM, dimensional inspection, or advanced metrology is a plus.
- Experience with manufacturing process validation, including IQ/OQ/PQ, is preferred.
- Six Sigma, CQE, CSSGB, or other quality-related certification is a plus.
Benefits
- Health Insurance (Medical/Dental/Vision) paid 100% for employees Life insurance policy Safe Harbor 401(K) plan 401(K) match Paid time off (vacation/sick/holidays/floating holiday) Referral Program * We do not offer visa sponsorship*
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