Quality Engineer
Vantedge Medical · Stockton, CA · 2 wk ago
Quality Assurance$87k–$115k/yrFull-time
About the role
Vander-Bend is a U.S.-based manufacturer focused on precision infrastructure for AI. The Quality Engineer will support quality activities in Stockton, CA, focusing on product/process improvement, supplier quality, and compliance with ISO 9001 and ISO 13485.
Responsibilities
- Analyze quality data to identify systemic issues and lead cross-functional improvement initiatives.
- Partner with Supply Chain and suppliers to drive supplier quality improvements, including corrective actions and performance monitoring.
- Develop, track, and report key process performance metrics to ensure manufacturing processes meet quality and yield targets.
- Lead or support APQP/PPAP activities, including pFMEA, Control Plans, process capability studies, and GR&R.
- Manage nonconforming materials, customer complaints, and returns, ensuring timely root cause analysis and effective corrective/preventive actions.
- Support and maintain compliance with ISO 9001 and ISO 13485 Quality Management Systems, including audit readiness and documentation control.
- Author, review, and update standard operating procedures, work instructions, and quality documentation.
- Develop and execute equipment validation protocols and generate validation reports.
- Collaborate cross-functionally with Manufacturing, Engineering, and Quality teams to resolve quality issues and implement sustainable solutions.
- Perform additional duties as assigned to support departmental and organizational objectives.
Requirements
- Bachelor’s degree in Quality, Mechanical, Industrial Engineering, or related field.
- Minimum 2+ years of quality engineering experience in a manufacturing environment (sheet metal or similar preferred).
- Strong knowledge of quality systems and standards, including ISO 9001 and/or ISO 13485.
- Experience with core quality tools and methodologies:
- Root cause analysis (5 Whys, Fishbone)
- FMEA (Design/Process)
- Statistical Process Control (SPC)
- Process capability (Cp/Cpk)
- Experience with APQP/PPAP processes and documentation requirements.
- Experience with measurement system analysis (MSA/GR&R).
- Knowledge of statistical analysis software (Minitab, JMP, or equivalent).
- Strong analytical and problem-solving skills with a data-driven approach.
- Ability to interpret technical drawings, specifications, and manufacturing processes.
- Effective communication and collaboration skills across cross-functional teams.
- Strong documentation and technical writing abilities (procedures, reports, validations).
- Ability to manage multiple priorities in a fast-paced manufacturing environment.
- Ability to create, review, and revise operating procedures, work instructions in English.
- Specific training and demonstrated success in applying quality problem solving methods, such as fishbone diagrams, 5 why, FMEA, process capability analysis, hypothesis testing, DoE, SPC, etc.
- Minitab, JMP or other statistical software capabilities.