Senior Quality Engineer

Company Overview Promex Industries is a leading provider of custom assembly solutions for Medical and Biotech Devices. With a rich history rooted in Silicon Valley, the company specializes in complex microelectronics and small component assemblies, offering a seamless transition from prototype to full-scale production within a fully integrated US-based facility. Position Summary: The Sr. Quality Assurance Engineer will develop, implement, and maintain quality protocols and methods to ensure the quality and compliance of products. The role involves developing and improving control procedures, analyzing defect /yield trends and driving corrective actions in the context of issue resolution and continuous improvement. The role focuses on factory operations and supporting supplier quality related activities. Essential Duties: Develop, implement and improve quality control and assurance processes. Collaborate with the engineering group on product program development, including converting compliance requirements to internal processes, developing Process Failure Modes and Effects Analysis (pFMEA), control plans, work instructions, Statistical Process Control (SPC), etc. Provide leadership in best practices regarding handling product and process issues, including root cause analysis and corrective action. Collect and analyze product quality data from all sources and drive continual improvement initiatives in operation process efficiencies and effectiveness. Perform hands-on metrology and inspection, qualify inspection processes, and train operators and inspectors on inspection tools, methods, and procedures. Support internal and external quality audits. Other Duties & Responsibilities (Optional) Conduct inspections Minimum Qualifications: Bachelor’s degree in engineering A minimum of 5 years of related experience in quality engineering, quality control, or quality assurance in industries such as microcircuit, PCBA, telecommunication, medical device, or IC, with at least 10 years of total work experience. Strong understanding of technical documents and standards. Knowledge of the physical and chemical attributes of materials, components, and assemblies. Proficiency in statistics, databases, and measurement systems. Familiarity with problem-solving methods such as 5-Why, Fishbone, 6M, 8D, etc. Effective communication skills for interaction with management, operations personnel, and engineering teams. Knowledge and experience with ISO 9001. Proficiency in SolidWorks 3D CAD modeling and engineering drawing creation. Key Competencies: Familiarity with quality engineering principles Attention to technical details Problem-solving skills Communication skills Manual dexterity Self-driven Preferred Skills: Proficiency in JMP, Minitab, or Tableau. Familiarity with ISO 13485, 21 CFR 820, ITAR and RoHS regulations. Knowledge and experiences of Mil-Std-883, IPC-A-610, ASME Y14.5. Experience with Lean Six Sigma methodologies. Knowledge of supply chain management. Experience in programming and operating MicroVu, Nikon, Keyence 3D optical profiler, CSAM, or similar analytical tools. Work Environment: · Combination of quality office and manufacturing/inspection-lab environment, including ESD-controlled areas and cleanrooms; requires wearing ESD/cleanroom equipment. · Regular computer work for record maintenance, plus periods of sitting or standing at microscopes and inspection stations with close visual work and fine hand manipulation. · Occasionally lifts and moves materials up to 25 lbs. · Works with XRF equipment that emits ionizing radiation; must follow the company radiation safety program. · This position may require access to export-controlled (ITAR) technical data; so, the candidate must be a U.S. citizen or permanent resident. Join us to be part of a forward-thinking organization dedicated to pioneering high-quality solutions in the medical device and biotech sectors! Pay: $134,000.00 - $144,000.00 per y…

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