Quality Engineer
Job in
Stockton, San Joaquin County, California, 95202, USA
Listed on 2026-07-09
Listing for:
Vantedge Medical Company
Full Time
position Listed on 2026-07-09
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
Quality Engineer
Full-time | Permanent
Salaried | $87K - $115k
About the RoleThe Quality Engineer will provide support for product/process quality activities within Vantedge’s Vander-Bend Sheet Metal Manufacturing business in Stockton, CA. Areas of assignment may include Product/Process improvement efforts, equipment validations, supplier quality performance and quality systems support.
Responsibilities- Analyze quality data (CAPA, complaints, yield trends) to identify systemic issues and lead cross-functional improvement initiatives to enhance product and process performance.
- 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 (KPIs) 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 (NCMR), 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 (QMS), including audit readiness and documentation control.
- Author, review, and update standard operating procedures (SOPs), work instructions, and quality documentation.
- Develop and execute equipment validation protocols (IQ/OQ/PQ) 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.
- 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)
- Familiarity 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 method, such as fishbone diagrams, 5 why, FMEA, process capability analysis, hypothesis testing, DoE, SPC, etc.
- Minitab, JMP or other statistical software capabilities.
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