Manager Quality Improvement & CAPA

Hollister
Any Location, IL
Job Description
The Manager is responsible for leading, maintaining and continuously improving key elements of Hollister's Quality Management System (QMS) worldwide. The role will provide leadership, guidance and global support across all Hollister locations. The Manager will maintain proficiency on standards, regulations and guidance documents in order to provide continuing awareness on changing requirements and ensure compliance. This role will contribute to Hollister's mission, vision and strategic plan by leading a compliant, suitable and effective CAPA and Nonconformance programs and driving improvement initiatives aligned with best industry practices

Requirements

  • Provides leadership for establishment, improvement and maintenance of Hollister's CAPA and Nonconformance programs.
  • Lead, understand, champion and implement new regulations and guidelines to ensure compliance with ISO 13485 standards, 21CFRPart820 EUMDR, and other regulations as applicable.
  • Manage and govern the CAPA process. Act as CAPA subject matter expert & coordinator for the Libertyville location
  • Provides guidance, direction and support across all sites and helps drive best practices
  • Conducts assessment of changing standards, regulations and guidance documents, and identifies any needed changes to internal policies, procedures, processes, or practice
  • Collaborates extensively across manufacturing sites and across functions including Quality, Regulatory Affairs, IT, Operations, R&D and other departments as applicable
  • Provides education on relevant quality systems and processes, and drives accountability across the organization
  • Analyzes process performance based on quality data & metrics and provides recommendations for improvement as applicable
  • Maintains up to date knowledge of all areas of responsibility which impact the Hollister Quality Management System.

Benefits

  • Health, Dental, and Vision Insurance
  • 401(k) and/or Pension Plan
  • Life Insurance
  • Paid Time Off
  • Wellness Programs
  • Employee Assistance Program
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