• Direct the Site Quality Management System, fully integrated into the Invacare Corporate Quality Management System, including cross-functional and site-specific processes. The role is responsible for facility compliance covering voluntary, regulatory and company quality requirements and will champion quality initiatives at all levels of the organization.
• 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, Health Canada, etc.)
• Oversee all Quality related communications and training requirements for all site employees. Responsible for maintenance of all manufacturing process documentation
• Establish positive relationships with outside agencies.
• 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
• Report on Quality System effectiveness and requirements to management team as required including preparing and executing facility Quality Management Reviews.
• Participate in selected global initiatives to share best practices and leverage quality & process engineering synergies.
• Acts as engineering liaison for manufacturability of new designs, support local R&D programs, design transfer and quality issue resolution.
• Act as Management Representative for Quality at the Site.
• Develop a team environment that values diversity and uses various individual’s strengths to the benefit of the team and the organization.
• 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
• Define processes, tooling, materials and equipment for operations
• 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
• Work closely with Purchasing/Materials on supplier related issues
• Responsible product support for correction and enhancement of design documentation
• Ensure that all required training is identified for and completed by all direct reports.
• Work with Manufacturing/Purchasing in make/buy analysis
• Responsible for manufacturing engineering aspects of cost reduction program
• Ensure that all required training is identified for and completed by all direct reports
• Evaluate staffing needs and costs; identifies, hires and promotes individuals with the right skills and competencies necessary to achieve superior results
• Develop a team environment that values diversity and uses various individual’s strengths to the benefit of the team
• Exhibit positivity, flexibility, creativity, and a willingness to take on new responsibilities as requested or required.

Required Skills Required Experience

1. Ability to follow detailed instructions
2. Some degree of judgement is required in carrying out instructions, handling tools, positioning work and the performance of simple operations
3. Frequent visual attention while performing work
4. Ability to read, write and perform simple math
5. Use simple fixed gauges and other instrument not requiring interpretation

Physical Demand and Working Conditions:

1. Sustained physical effort in handling tools and materials, moving equipment.
2. Will work in various locations within the plant under varying conditions such as heat, cold, dirt but not continually