Director of Quality - Medical Device Manufacturing

Responsibilities

• Lead and assist in the development of direct reports to achieve desired results.
• Communicate department goals and objectives, ensuring resources are distributed appropriately.
• Maintain regular two way dialogue with direct reports on work and results.
• Collaboratively create development plans and coach individuals in achieving them.
• Ensure Quality department’s participation in the Growtth (Lean) program.
• Ensure systems and specific product procedures are in place to release product meeting defined requirements.
• Responsible for leading the development and management of an effective and compliant quality system by working closely with various cross-functional members.
• Ensure quality performance metrics are implemented, monitored and addressed.
• Report to management on the performance of the Quality Management System.
• Act as the primary contact for customers regarding quality related issues / activities.
• Lead / oversee customer / external audit(s).
• Address customer concerns to support strategic approach to the regulations.
• Serve as site Management Representative.
• Coordinate and conduct management review meetings and ensure closures of management review items.
• Ensure continuing suitability, adequacy, and effectiveness of Freudenberg Medical Quality Management System.
• Oversee CAPA Review Board (CRB) and ensure appropriate actions are taken to resolve QNs in a timely manner.
• Responsible for implementing new or revised global quality systems requirements.
• Report and resolve customer recalls and field complaints.
• Participate in strategic planning activities to ensure that quality related requirements are included in strategic goals and objectives.
• Provide quality solutions to support business activities and other assigned task to support the business.
• Promote the awareness of quality throughout the business.

• Bachelor’s degree in Science, Engineering, Manufacturing or related field (Master s degree preferred).
• Medical Device Manufacturing experience is required
• Thorough knowledge of medical devices quality systems (ISO
  13485/FDA).
• Knowledge of LEAN and Six Sigma methodologies is desirable.
• A minimum of ten (10) years of relevant progressive experience within a similar environment, with five or more successful years in a leadership position.
• Thorough knowledge of quality management systems and associated regulatory requirements (ISO 13485, FDA etc.).
• Experience using SAP ERP software and Proficient in Microsoft Office Suite.
• Demonstrable ability to achieve goals through collaborating, influencing and interaction at all levels across the business/function.

• Quality Inspection Experience
• ISO 13485
• Quality Control Experience
• Quality Control Data Analysis
• Regulatory / Legal Contracts