Quality Engineer
$87k - $115kVantedge Medical Company
Quality Engineer Full-time | Permanent Salaried | $87K - $115k About the Role The 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. 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) 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. #J-18808-Ljbffr
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