Director of Quality
About The Position
Responsibilitiesarrow_right 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. Qualificationsarrow_right Bachelor's degree in Science, Engineering, Manufacturing or related field (Master's degree preferred). Thorough knowledge of medical devices quality systems (ISO13485/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.
Requirements
- Bachelor's degree in Science, Engineering, Manufacturing or related field (Master's degree preferred).
- Thorough knowledge of medical devices quality systems (ISO13485/FDA).
- 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.
Nice To Haves
- Knowledge of LEAN and Six Sigma methodologies is desirable.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Industry
Machinery Manufacturing
Number of Employees
5,001-10,000 employees
