Description
Responsibilities:* Works closely with Device Development and deviceCMOs to assure that combination products maintain their requirements and specifications and are compliant with the Quality System*
Liaises with technical groups to review and revise specifications based on design and/or process changes*
Supports root cause analysis in the implementation of corrective actions*
Responsible for continual improvement activities and liaises with experts to apply appropriate improvement tools*
Provides technical consultation on the development of fixtures, methods, test equipment, and tooling in order to continually improve process and products *
Establishes quality inspection processes and supports quality activities to ensure that products and processes comply with the relevant requirements of the quality management system.*
Supports internal/external audits and vendor qualification, including closing out audit findings and determining proper corrective and preventive actions.*
Responsible for planning, organizing, and managing the overall testing activities of quality functions.*
Skills * 10+ years experience in a Quality Engineering role for a pharmaceutical or medical device company* Quality Engineer certification (ASQ) recommended* Experience leading and working with internal and external teams through end-to-end projects* Able to educate teams and organization on Design Controls and related topics* Demonstrated capability of ISO13485, 21CFR820 and ISO14971* Demonstrated capability of applying risk management concepts and tools * Understanding of the biotechnology industry and specifically combination products.* Hands on expertise in one or more areas including secondary packaging, device development, aseptic product development, and manufacturing* Well developed teamwork and collaboration skills and ability to communicate clearly and professionally both verbally and in writing. Experience working in a global environment is a plus. * Demonstrated problem solving and decision making skills including hands on working experience with tools Six Sigma / DMAIC is preferred
Education BS degree in an Engineering discipline, Graduate degree preferred