Quality Engineering Manager

POSITION SUMMARY Leads and participates in continuous improvement activities across business areas, focusing on instrumentation, chemistry, software, and testing. Directs and prioritizes tasks to ensure timely and accurate completion of tests and records. POSITION RESPONSIBILITIES Testing and Technical Oversight Manage the daily activities of workgroups and technicians, ensuring alignment with project goals. Lead problem-solving efforts for all aspects of testing. Generate, implement, and review Standard Operating Procedures (SOPs) and Standard Methods. Ensure testing is properly documented and conducted per written protocols. Oversee training and competency of PSG technicians. Product and Process Improvement Analyze data to identify product improvement opportunities. Design and execute experiments to expose and address product risks. Support development of specialized test fixtures, software, and systems for required testing. Analyze and report on product field performance (including summary reports). Assist in failure analysis of returned materials, components, and subassemblies. Initiate actions to enhance product robustness and reliability. Support manufacturing process improvement initiatives. Establish/refine process limits and develop inspection and test methods for production. Quality Assurance and Risk Management Implement and maintain a quality risk management process across the product lifecycle. Ensure operational excellence tools are used in quality procedures/processes. Provide QA support to validation activities (facilities, equipment, utilities, cleaning, process validation). Prepare and maintain the site Validation Master Plan. Oversee qualification protocols and reports. Review and approve process‑related change controls and change plans. Identify and communicate potential compliance gaps/risks to management. Support inspection readiness and regulatory site inspections. Continuous Improvement Drive Lean‑based continuous improvement to enhance cycle time, productivity, efficiency, and quality. Provide quality guidance and facilitate timely resolution of quality issues. Staffing and Leadership Responsibilities Foster leadership development and coaching; create a learning organization. Ensure training and development plans are established for QA associates. Develop budgets and resource plans for the Site Quality Budget. Support development of quality goals and targets. QUALIFICATIONS & REQUIRED/ PREFERRED SKILLS Education & Experience Bachelor’s degree in engineering or a scientific discipline, or equivalent relevant experience. 5–10 years in Quality Engineering in a regulated manufacturing environment (preferably medical devices). Minimum 3 years of leadership experience (preferred). Required Technical Skills & Competencies Knowledge of ISO 13485 and FDA 21 CFR 820; ability to ensure compliance with changing guidelines. Ability to troubleshoot problems and implement corrective action. Strong written and oral communication skills. Understanding of equipment used by technicians. Analytical, data‑driven problem‑solving skills. Experience with software programs including Excel, PowerPoint, Word, Minitab, or JMP. Statistical techniques, reliability test methods, electro‑mechanical aptitude, and software programming. Strong attention to detail. Apply an analytical/experimental mindset to learn from successes and failures. Self‑awareness and openness to feedback. Physical Requirements Ability to stand, bend, squat, and lift up to 25–30 lbs. Use required PPE. Onsite presence required in Union City, CA. Must remain drug‑free; drug screening completed prior to starting. #J-18808-Ljbffr