The Senior Manufacturing Quality Engineer is responsible for ensuring quality process and standards are in place and followed in the manufacture of RefleXion products. This person will engage with the New Product Introduction team to ensure that processes and procedures developed for design transfer comply with and enable compliance and efficient operations. The person will support equipment qualifications and process validation activities in manufacturing to meet quality standards and regulatory requirements. This person represents the Quality Assurance function in manufacturing and will ensure that appropriate process controls are in place to ensure product conformity.
- Develop and improve manufacturing and quality processes.
- Facilitate design transfer for manufacturing activities from a quality perspective.
- Participate in cross-functional reviews of pFMEAs.
- Align manufacturing process instruction (MPI) and travelers with product/subsystems/system requirements and ensure that appropriate in process inspection steps are included.
- Monitor product quality performance through manufacturing data such as yield, rework and NCR’s and by applying statistical process control (SPC) and CPK analysis of critical raw materials/parts and process parameters.
- Participate in the selection of inspection equipment required to support tests necessary to support part/assemblies/product testing for both in process and product release activities.
- Work with engineering team to develop methods and write detailed Quality Inspection Plans (QIP) for incoming inspection for parts/assemblies/materials.
- Coordinate with engineering team to appropriately set the calibration requirements and preventive maintenance schedule for equipment/tools/fixtures.
- Conduct and support IQ, OQ, PQ for equipment/tools/fixtures.
- Design and conduct gage R&R (Range and Repeatability) studies.
- Ensure continuous traceability from purchase order, to drawing, to PLM, to ERP system and that all traceability is documented, linked or captured in DHR.
- Conduct root cause analysis using appropriate methods (e.g. 8-D Corrective & Preventive Action, Fishbone Diagrams, 5 Whys, DMAIC, etc.) and implement corrective actions for identified issues.
- Coordinate and perform quality process audits for compliance with standards and regulations.
- Report on level of systems compliance, areas requiring changes or improvements and recommend corrective actions and track and document related efforts and results.
- Monitor findings for verification of effectiveness and ensure closure of related tasks.
- Perform other duties as assigned.
- BS Degree in Mechanical or Electrical Engineering (or equivalent experience)
- ASQ Certifications (CQE, CMQ, SSGB, SSBB, CQA) a plus.
- Experience applying regulatory standards and process control measures to complex electromechanical capital equipment and related software.
- Minimum three 5 years’ experience in manufacturing quality with a minimum of 7 years’ experience in a medical device design, manufacturing, or quality engineering capital equipment
- Experience in manufacturing medical devices in conformance with FDA 820 Quality System Regulation, ISO 13485:2016, and ISO 14971:2012.