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Freudenberg Medical · 6 hours ago

Director of Quality

Jeffersonville, IN

Full-time

Onsite

Director/Executive

10+ years exp

Freudenberg Medical is a trusted Contract Manufacturing Organization (CDMO) partner, delivering high-quality solutions for medical device and pharmaceutical companies. The Director of Quality will lead the development of the quality system, ensure compliance with regulations, and promote quality awareness throughout the organization.

ManufacturingMedical Device

No H1B

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

Qualification

Medical devices quality systemsQuality management systemsLEAN methodologiesSix Sigma methodologiesSAP ERP softwareMicrosoft Office SuiteInfluencingLeadershipCollaborationCommunication

Required

Bachelor's degree in Science, Engineering, Manufacturing or related field

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

Proficient in Microsoft Office Suite

Demonstrable ability to achieve goals through collaborating, influencing and interaction at all levels across the business/function