Senior Quality Engineer

Job Type: Full Time / On-Site Salary Range: $135,000 - $145,000 with a 6% Bonus How You’ll Make an Impact As the Senior Quality Engineer you’ll be at the forefront of our innovation by providing tactical support to the development of new manufacturing and quality processes. The Quality Engineer provides engineering support of the Company’s Quality Systems, ensuring compliance with ISO 13485, CFR Title 21 Part 820, ISO 14971 and other applicable standards as well as providing product engineering support by assessing risk, process capabilities, developing and implementing effective quality assurance controls. The Quality Engineer must have a “hands‑on” approach to problem solving, problem investigation and data mining. In this role, you will: Develop, write, and assist with the implementation of effective quality assurance controls Write validation and verification plans and protocols, assist with IQ/OQ/PQ activities, including finalize reports. Coordinate the identification, assignment, monitoring, and completion of process and/or product improvement projects. Work with the operations and engineering functions to coordinate pilot production of new products Coordinate the reporting, analysis, and resolution of material nonconformance occurrences. Apply statistical and quality tools to analyze data and perform thorough Root Cause Analysis (e.g., Fishbone Diagram, 6M, 5Whys), execute CAPA processes and improve process capabilities (e.g.,5S, Lean, 6 Sigma, DOE, SPC) Conduct risk analysis, create or revise Control Plans for new and existing products Complete projects in a manner consistent with corporate objectives. Provide support in the rapid resolution of product complaints and/or safety issues. Provide quality assurance appraisal of suppliers. Conduct quality process and product audits and develop responsive corrective action plans. Technical writing to document current practices to meet quality requirements necessary for QMS. Support completion of Customer requests (e.g., Supplier surveys, EU MDR compliance Declarations, etc.) As directed, provide specific support for operational quality management system programs. Perform other required duties as needed in addition to the essential duties and responsibilities described above. Required Qualifications that Enables Your Success Bachelor’s Degree in Engineering or related technical discipline. 2 + years of experience in manufacturing, engineering or quality Experience in medical device industry. Experience and familiarity with tools for root cause analysis and defect analysis, including Failure Mode and Effect Analysis (FMEA). Experience with developing and implementing process controls, corrective and preventive action, and product quality improvement. Experience with DOE. Experience with verification and validation activities. Ability to conduct process analysis, and capability assessments. Able to develop and establish Control Plans, FMEAs, PPAPs. Experience with SPC. Able to apply statistical methods, and analysis utilizing statistical software such as Minitab, JMP or Statgraphics. Familiarity with test methods validations or measurement systems analysis, test and inspection equipment, and valid acceptance sampling plans. Experience with quality management systems. Experience with Lean, or Six Sigma manufacturing principles. Able to lead and influence others to drive change. Strong written and verbal communication skills. Your Work Environment Standing, walking, or operating equipment for extended periods Working in a lab or manufacturing setting with appropriate PPE provided Use of computers and digital tools in an office or hybrid environment Occasional lifting or movement of materials Adherence to rigorous safety protocols and ergonomic standards Benefits that Empower You Competitive salary with performance-based bonus plans 401(k) match + Age-Weighted Defined Contribution Health Savings Account (HSA) Paid holidays, vacation, and parental leave Job Segment: Senior Quality Engineer, Manufacturing Engineer, Quality Engineer, Lean Six Sigma, Chemical Research, Engineering, Management Nearest Major Market: Corona Nearest Secondary Market: Los Angeles #J-18808-Ljbffr