Manager Quality Assurance

R.R. Donnelley & Sons-posted about 1 year ago
Full-time • Manager
Plover, WI
10,001+ employees
Printing and Related Support Activities
Resume
Match Score
Upload and Match ResumeTrack Jobs with Teal

The Quality/Regulatory Manager at RRD is responsible for overseeing the quality assurance processes and regulatory compliance of medical device manufacturing. This role involves directing and managing quality systems in accordance with FDA and ISO standards, ensuring product quality, and fostering a culture of continuous improvement within the organization.

  • Plan and implement programs that ensure product quality in compliance with QMS standards.
  • Lead the organization in the implementation of new products.
  • Drive the culture of continuous improvement.
  • Provide guidance for process validation strategies.
  • Manage the preparation and updating of quality documentation based on ISO 13485:2016, ISO 14971, and FDA 21CFR820 standards.
  • Maintain daily communication with departments to follow established QMS processes.
  • Ensure proper training for department personnel to perform job duties effectively.
  • Oversee the effective use and further implementation of eQMS systems.
  • Collaborate with customers and suppliers to develop and approve Quality agreements.
  • Ensure operational quality controls incorporate customer and regulatory requirements.
  • Implement best practices and industry standards in QMS applications.
  • Manage site quality plans for large changes and implementations.
  • Ensure manufactured products are licensed, produced, and marked per local regulations.
  • Build and develop a team of quality and regulatory professionals.
  • Experience in quality management systems and regulatory compliance in the medical device industry.
  • Strong knowledge of FDA 21CFR820 and ISO 13485 standards.
  • Proven leadership skills in managing quality assurance teams.
  • Ability to implement and drive continuous improvement initiatives.
  • Experience in process validation and quality documentation management.
  • Familiarity with ISO 14971 risk management standards.
  • Experience with electronic Quality Management Systems (eQMS).
  • Strong communication and interpersonal skills.
  • Equal Opportunity/Affirmative Action employer policies.
  • Diversity and inclusion initiatives.
Track Jobs with Teal

Job Search Resources

•
AI Resume Builder
•
Quality Assurance Resume Examples
•
Quality Assurance Cover Letter Examples

Tools

Career Hubs

Guides

Company

© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service