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Manager Quality Assurance - PLOVER, WI,

Job Information

Job Order ID :
WI3800882
# of Positions :
1
Minimum Education Level :
Bachelor's Degree
Experience Required :
Training :
Bachelors Degree
Duration :
Shift :
Unspecified
Hours per week:
40

Job Description

 
JOB REQUIREMENTS: Company Description RRD is a leading global provider
of marketing, packaging, print, and supply chain solutions that elevate
engagement across the complete customer journey. The company offers the
industry\'s most trusted portfolio of creative execution and world-wide
business process consulting, with services designed to lower
environmental impact. With 22,000 clients, including 93% of the Fortune
100, and 32,000 employees across 28 countries, RRD brings the expertise,
execution, and scale designed to transform customer touchpoints into
meaningful moments of impact. 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 to Director
Quality and Regulatory Affairs. RESPONSIBILITIES: Plan and implement
programs that ensure product quality in compliance with QMS standards.
Leads the organization is implementation of new products. Implements and
drives the culture of continuous improvement. Provide guidance to the
site for process validation strategies. Manage the preparation, updating
in the system of quality documentation, basing the processes on the
standard of ISO 13485:2016, ISO 14971 and FDA 21CFR820. Maintain daily
communication with the Departments to follow the established QMS
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. Oversee the effective use and further
impolementation of eQMS systems. Work with customer and suppliers to
develop and approve Quality agreements. Ensures adequate operational
quality controls are developed to incorporate customer and regulatory
requirements. Ensure best practices are impolemented and industry
standards are applied with QMS applications. Implements the risk based
approach to the site QMS and operations. Manage site quality plans for
large changes and implementations. Ensure manufactured products are
appropriately licensed, produced and marked per local state and federal
regulations. Builds and devlops a team of quality and regulatory
professionals to support world class medical device\... For full info
follow application link. RR Donnelley is an EEO/AA including Vets and
Disabled Employer RR Donnelley is an Equal Opportunity/Affirmative
Action employer. The company\'s policy is to select, place and deal with
all its employees without discrimination based on race, religion, color,
national origin, sex, gender identity or expression, age, disability,
perceived disability, sexual orientation, protected Veteran status,
genetic information or on the basis of any other status protected by
applicable federal, state or local law. \*\*\*\*\* APPLICATION
INSTRUCTIONS: Apply Online: ipc.us/t/F33A2FE7079D443D

Company Information

Name :
R R DONNELLEY & SONS CO

Application Information

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