Quality Assurance Manager

RR DonnelleyPlover, WI
9d$80,700 - $129,200Onsite

About The Position

RRD is seeking an experience Quality Manager for our Plover, WI facility! He/She will be responsible for directing, planning, organizing and controlling the processes, procedures, policies and activities for the assurance of the quality of the products according to the guidelines established by the clients and in compliance with the ISO 9001.

Requirements

  • Bachelor degree in related function required
  • Five years or more of experience in equivalent role
  • Excellent oral and written communication
  • Strong management and communication skills
  • Skills to make presentations to top management
  • The incumbent is required to demonstrate a positive attitude on a consistent basis when working with others.
  • Ability to work in matrix management and able to work collaboratively and cross-functionally as well as across the organization.
  • Broad understanding of manufacturing processes.
  • Strong organizational and communication skills.
  • Ability to conduct training and present material to a wide range of audiences.
  • Must be able to work on personal initiative, have the flexibility to manage change, be able to multi-task and prioritize workload.
  • Must be confident in their ability to make decisions balancing business requirements with quality requirements and the associated risks.
  • Must possess excellent computer skills, i.e.: Microsoft Office including Excel, Word and Power Point.

Nice To Haves

  • Advanced degree strongly preferred
  • JD Edwards or an ERP system experience is a plus.
  • Certification in ISO 9001 & 13485 desirable.

Responsibilities

  • Plan and implement programs that ensure quality according to the requirements and guidelines of customers and in compliance with quality standards.
  • Implements and drives the culture of continuous improvement.
  • Manage the preparation, updating in the system of quality documentation, basing the processes on the standard of ISO 9001: 2015 and ISO 13485:2016 and FDA.
  • Maintain daily communication with the Departments to follow the established processes and together take actions for the improvement or problems solution detected in the product or in the processes.
  • Responsible to follow up and ensure that the personnel of the Department under her responsability have the proper training to performance the job duties.
  • Ensures adequate operational quality controls are developed to incorpórate customer and regulatory requirements.
  • Implements the risk based approach to the site QMS and operations.
  • Regulatory ensure manufactured products are appropriately licensed, produced and marketed.
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