Senior Quality Engineer

Job Description
RRD - Plover, WI is a medical device contract manufacturing facility. The Quality/Regulatory Manager is responsible for directing, planning, organizing and controlling the processes, procedures, policies and activities for the assurance of the quality of the products according to specifications and in compliance with FDA 21CFR820 &
ISO 13485, reporting toDirector Quality and Regulatory Affairs.
This role will ensure all processes, materials, and practices comply with quality system requirements. Reporting to the Quality Manager, will work closely with Operations, Customer Account team, Industrial Engineering, Supply Chain and other departments to resolve quality issues with processes, products, and materials.
*RELOCATION ASSISTANCE AVAILABLE!
Maintain and manage the Quality Management System to ensure compliance to ISO (phone number removed), FDA 820, and other international QMS standards as applicable.
Drive continuous improvement within the Quality Management System.
Develop work instructions, SOPs, and train all levels of staff to controlled documents.
Promote Quality Culture throughout the organization.
Train and mentor junior engineers, technicians, and inspectors.
Perform analyses of programs and prepares responsive quality plans, procedures, schedules, and resource allocations for top-quality support.
Communicate with internal and external customers and vendors to resolve quality issues with process, product and material inclusive of Root Cause Investigation, Corrective and Preventative action and monitoring for effectiveness.
Provide support for Assembly/Test/Inspection personnel, including executing workmanship improvement plans, developing inspection methods and criteria, specifying appropriate sampling plans, interpreting and revising specifications, and processing non-conforming materials.
Lead in resolving customer quality issues, driving root causes, and corrective action on process and product quality problems.
Lead risk management activities per ISO (phone number removed). - Interface with the customers’ quality organization. - Review, investigate and respond to complaints.
Develop and provide quality reports including trending and analysis.
Participate in the Material Review Board for the site.
Lead, participate in, and satisfactorily complete all training programs required of the assigned position.
Contribute to process validation efforts.
Perform other duties assigned by management