Quality Manager

Responsibilities: Responsible for leading, development, and management of effective and compliant quality systems and work closely with various cross functional members of site to ensure all requirements are described and meet the needs of regulations and functional excellence. Serve as Management Representative responsible for representing site to all regulatory bodies including registered notified bodies and ensuring management review activities are conducted per regulations. Manage all client quality systems audits and ensure timely response to any audit concerns. Act as the primary contact for customers regarding quality related issues/activities. Ensure all field complaints are responded per regulatory requirements. Participate in strategic planning activities to ensure that all quality related requirements are considered when establishing strategic goals and objectives. Participate in new product/project development to ensure quality requirements are established. Work directly with operating entities to ensure that management controls, product life cycle requirements including risk management, inspections, improve yield and product quality, statistical process control analyses and audits are conducted on a continuing basis as specified to 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. Participate and support lean/continuous improvement initiatives and safety initiatives. Ensure the quality activities are planned; resources allocated; priorities established and activities executed to meet goals. Working within the people management systems in the Company to develop others (performance management, rewards and selection process); and Creating an energizing work environment that supports the Company’s high performance culture while ensuring and efficient and flexible organization. Qualifications: 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 and FDA GMP and QSR. Electronic Quality Management System. Able to review and analyze data and documentation. Effective and competent management, leadership, and organizational skills required and valued as part of the leadership team. The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law. Freudenberg Medical LLC #J-18808-Ljbffr