- Maintain and drive improvements to all aspects of Site Quality & Process Engineering Planning.
- Ensure consistent application of plans and programs to drive compliance for all applicable governmental regulations (ISO13485, FDA, MDD, MHLW, CFDA, KFDA, etc.)
- Oversee all Quality related communications and training requirements for all site employees. Responsible for maintenance of all manufacturing process documentation
- Partner effectively with Operations, Engineering, Global Supply Chain, and other cross functional departments to ensure quality standards are being met at the site.
- Ensure site audit readiness and host Quality System audits and inspections.
- Oversee the Corrective Action / Preventive Action (CAPA) activities, Supplier Corrective Actions, and Quality Engineering.
- Drive site quality & process engineering objectives, metrics, reporting and operating mechanisms.
- Conduct analysis of quality indicators to identify trends, drives and support root cause investigations, and implementation of appropriate corrective actions.
- Evaluate staffing needs and costs related to the Plant Quality teams; identify, hire, and promote individuals with the correct skills and competencies to achieve superior results
- Acts as engineering liaison for manufacturability of new designs, support local R&D programs, design transfer and quality issue resolution.
- Responsible for leading the implementation of new products into manufacturing
- Direct and participate in the development of new and alternative manufacturing methods and processes
- Direct all project activity to include coordination through manufacturing and design engineering
- Evaluate and recommend capital expenditures for tooling and equipment
- Responsible for design and implementation of plant layout in conjunction with manufacturing and facility managers
- Direct and assist subordinate engineers working with quality engineering in resolving quality issues
- Responsible product support for correction and enhancement of design documentation
- Responsible for manufacturing engineering aspects of cost reduction programs
Our client, a global leader in home and long-term-care medical products, is seeking an experienced Site Quality and Process Engineering Manager for their plant in the Orlando, Florida metropolitan area. Will direct the Site Quality Management System as well all project and manufacturing engineering. Will supervise a team of quality and engineering associates. Annual bonus and excellent benefits including medical, dental, vision, HRA, FSA. Relocation assistance available.
- BS Degree in Engineering; Masters Degree preferred
- Minimum seven years of managerial experience in a medical device/equipment manufacturing environment
- Leadership experience with FDA’s Quality System Regulations, ISO9001, ISO13485, Medical Device Directive (MDD) and/or other international quality systems requirements.
- ASQ Certified Manager of Quality/Operational Excellence (CMQ/OE), ASQ Certified Quality Engineer (CQE), ASQ Certified Quality Auditor (CQA), or equivalent preferred.
- Experience directing capital projects and project activities as well as manufacturing engineering experience
- Strong analytical, numerical, mechanical and reasoning abilities
- Able to execute/review design and implementation of plant layout
- Demonstrated leadership abilities and previous supervisory experience