The Manufacturing planner III will be responsible for planning and scheduling all aspect of production. The position will require complex analysis of data to determine the most cost effective, optimal production schedule that Manufacturing can successfully execute. Involve with the new product introduction and transfers, includes interaction with other departments to ensure that company objectives are met for business revenues and customer satisfaction. Individual will drive continuously process improvement to improve key metrics such as OTIF, Backorder, Schedule Attainment, & Utilization. Strong analytical, interpersonal, and communication skills are a must. Job Requirements: Responsible for key performance indicators such as on-time delivery, maintaining Safety Stock levels of products and internal raw material shortages levels. Coordinate production workflow for multiple product lines. Prepare and submit status and performance reports (PMD). Maintenance...

Department specific/Non-essential responsibilities: • Perform internal and external audits of systems and suppliers • Filing and management of documentation when required • Supporting other Quality System Functions Experience / Skills: • 7+ years of experience in a cGMP Quality Assurance/Compliant environment (medical devices preferred) • Ability to utilize statistics at a moderate level for trending and interpretation of statistical data Organizational Relationship/Scope: The Senior Quality Engineer collaborates closely with Manufacturing, Quality Control, Facilities, Materials Management, Regulatory Affairs, and Process Development. The individual must be able to perform in a fast-paced environment with strict adherence to timelines. The position is during normal working hours M-F, but may be required to work extra hours or on weekends or holidays in order to support Manufacturing Quality activities. Working Conditions: The Senior...

Quality Engineering is responsible for product and service quality evaluation and control. Works cross-functionally in the development and or maintenance of products or services. The Engineer is involved in resolving the equipment and process-related production issues, activities including equipment, process, materials and method validation as well as statistical analysis and metrics to analyze those systems and processes being measured.Demonstrates intermediate knowledge of quality engineering policies, principles and best practices Job Requirements: Demonstrates intermediate knowledge of FDA/ISO requirements Applies statistical sample size calculations to work for quality determination on projects of intermediate scope/complexity May act as mentor to less experienced team members Applies intermediate understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to support work with little or no supervision Writes test protocol, tests, collects data, and writes reports...