17 days old

Quality Manager (550629)

Zimmer Biomet Spine, Inc
Westminster, CO
  • Job Code

Job Summary

This position is responsible for developing and standardizing the requirements for processes. This position ensures that the processes are in compliance with applicable regulations and guidance requirements. This individual will stay current with changing regulations and guidance requirements worldwide and provide effective guidance and oversight to Zimmer Biomet locations as applicable. This role will interface with other areas of the Company and with varying levels of management.

Principal Duties and Responsibilities

  • Partners with Zimmer Biomet sites as applicable to ensure compliance across the enterprise.

  • Partners with internal stakeholders to ensure quality, compliance, customer satisfaction, patient safety, and continuous improvement.

  • Supports activities to ensure surgeon confidence and satisfaction with Zimmer Biomet products.

  • Supports internal and external audit activities, and functions as subject matter expert for the product complaint process.

  • Ensures alignment with Corporate processes.

  • Ensures product complaint process complies with global regulatory requirements.

  • Ensures product complaint procedures reflect internal and regulatory requirements.

  • Ensures quality and compliance of product complaint files and investigations.

  • Manages the day to day activities of complaint handling personnel.

  • Supports product complaint file processing, as necessary.

  • Ensures the continuous improvement of product quality and processes through the monitoring of post market product quality issues and trends.

  • Ensures quality trend data is disseminated to the appropriate levels of the company for review and action if warranted.

  • Prepares and presents product complaint data and trends for management review.

  • Ensures product safety issues are quickly identified, understood from a patient risk standpoint, and escalated appropriately to ensure proper action and/or agency notification is taken.

  • Identifies and acts on process improvement opportunities.

  • Identifies and allocates resources, monitors resource requirements, escalates requirements to senior management as necessary.

  • Provides performance expectations and feedback to direct reports.

This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

Expected Areas of Competence

  • Ability to work towards in-depth knowledge of Zimmer Biomet products, their medical application, and their manufacturing processes.

  • Ability to answer product-related questions from within the company, the field, and competent authorities worldwide.

  • Ability to engage with regulatory investigators.

  • Ability to be subject matter expert in all areas of responsibility.

  • Ability to train others on all areas of responsibility.

  • Excellent problem solving skills.

  • Excellent project management skills.

  • Excellent written, oral, and presentation communication skills.

  • Detailed knowledge of regulatory authorities (domestic and international), guidance documents and standards.

  • Detailed knowledge of industry best practices for medical product complaint handling.

  • Ability to manage ongoing multiple tasks, be responsive to critical situations and changing priorities.

  • Ability to manage conflict.

  • Ability to identify qualified candidates to support processes in areas of responsibility.

  • Proficient knowledge of ISO 13485, Medical Device Directive, Canadian Medical Device Regulations, and/or FDA Quality Systems Regulations.

Education/Experience Requirements

  • Bachelors degree required, preferably in biology, health sciences, engineering, or nursing or Bachelors degree in another discipline with equivalent years of relevant experience.

  • 6+ years work experience required, preferably in Regulatory Affairs, Regulatory Compliance, or a Post Market Surveillance area.

  • 3+ years of management experience preferred.

  • Project Management experience, or PMP certification is a plus.

Travel Requirements

  • Up to 20%

Additional Information


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Quality Manager (550629)

Zimmer Biomet Spine, Inc
Westminster, CO

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Zimmer Biomet Spine, Inc
Westminster, CO

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