The Manager, Quality Systems Compliance will provide leadership in the implementation, maintenance, and improvement of company-wide quality management systems, procedures and support processes. Proactively monitors the various elements of the quality system to help ensure compliance with quality system regulations and applicable national and international quality standards. Ensures processes and tools are established to ensure ongoing compliance with applicable requirements. Supports external audits by the FDA, AATB, the Notified Body, other regulatory bodies and third parties, and coordinates responses to applicable audit findings. Manages the internal audit program to ensure company-wide compliance to applicable standards, regulations, and internal procedures. Provides support to internal functions in the application, maintenance and improvement of quality systems and department specific processes. Promotes quality achievements and performance improvements throughout the organization.
Educational Requirements / Qualifications
- Bachelor's Degree in Engineering or Science with at least 7-10 years' experience in an FDA regulated industry in medical devices and/or biologics.
- B.S. or higher degree in Engineering is preferred
- 1-2 years of experience in a management role with demonstrated leadership skills.
- Direct experience with FDA QSRs, ISO 13485, ISO 14971, MDD 93/42/EEC, 21CFR part 11, 210, 211, 600 and 1271 and AATB Standards
- Experience in leading external regulatory and/or third-party audits, i.e. FDA, ISO, AATB, etc.
- Demonstrated experience in building high-performing quality and/or related organizational teams.
- Excellent oral and written communication skills
- Excellent interpersonal and team building skills
- Ability to exercise creativity and judgment
Primary Responsibilities: The specific duties of Manager, Quality Systems Compliance include but are not limited to:
- Responsible for ensuring that Axogen's quality systems are in compliance with the applicable regulations and national & international quality standards
- Provides support to internal functions in the application, maintenance and improvement of quality systems, procedures and department specific processes
- Manages external audits by the FDA, AATB, the Notified Body, other regulatory bodies and third parties, and coordinates responses to applicable audit findings
- Ensures the coordination between Axogen facilities so changes in the quality management system are implemented with consideration to compliance and changing business needs
- Prepares performance reports and metrics for the Quality Management System
- Provides hands-on ownership for quality systems improvement projects to ensure various elements of the quality system continue to support changing business needs and goals
- Ensures efficient and effective processes and tools are established for compliance with AATB, QSR (21 CFR part 820), ISO 13485 standards requirements and 21CFR parts 11, 210, 211, and 1271
- Other responsibilities as assigned by management
Travel Requirements: Up to 25%