Freudenberg Medical LLC
QualityManager
“Quality Manager at Freudenberg Medical LLC. Skills: Quality systems, Regulatory compliance, Team leadership. Lead quality systems development and management. Represent site to regulatory bodies”
What You'll Achieve.
Ensure all requirements are described and meet the needs of regulations and functional excellence; Ensure management review activities are conduct per regulations; Ensure timely response to any audit concerns; Ensure all field complaints are response per regulatory requirements; Ensure that all quality related requirements are considered when establishing strategic goals and objectives; Ensure quality requirements are established; Enforce requirements and meet specifications; Ensure that all site quality performance indicators (QPI) metrics presented to the management are in sync with site and global requirements and metrics; Ensure the quality activities are resources priorities established and activities executed to meet goals
Industry & Context.
Able to review and analyze data and documentation
What They're Looking For.
Must Have
Bachelor's degree, 7 years of Quality, Manufacturing, and/or Product Development, experience, 5 years minimum of medical device experience, 5+ years experience in demonstrated ability to manage, coach and mentor employees, Experience in a metric driven culture, Previous experience participating in or leading a Quality audit or section of an audit, ISO Quality Systems requirements, FDA GMP, QSR, Electronic Quality Management System, Able to review and analyze data and documentation, Effective and competent management, leadership, and organizational skills
What You'll Do.
Lead quality systems development and management
Represent site to regulatory bodies
Manage client quality systems audits
Respond to audit concerns
Act as primary contact for customers
Ensure field complaints are responded
Participate in strategic planning
Ensure quality requirements are established
Work with operating entities
Ensure management controls are conducted
Improve yield and product quality
Ensure site quality performance indicators are in sync
Support lean/continuous improvement initiatives
Ensure quality activities are resourced
Create energizing work environment
How You'll Work.
Team & Collaboration
Work closely with various cross functional members of site; Work directly with operating entities
Communication Scope
Effective and competent management, leadership, and organizational skills
Process & Methodology
Participate in strategic planning activities, Participate in new product/project development
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