Director Quality Management (Sales and Service)

We are hiring a Director Quality Management (Sales & Service) to work hybrid out of our Telford, PA office.

The Director, Quality Management directs quality and regulatory activities in the Quality organization to ensure all business priorities are met while maintaining quality and regulatory objectives for all Sales and Service subsidiaries within the NA region including direct responsibility for the US subsidiary. Set the strategic and tactical objectives and provide functional guidance for Sales and Service Quality (including Environmental Health and Safety - EH&S) organization.

Assure and maintain a leading position of Draeger in customer perceived quality:

• Handle regional escalations of customer quality issues (complaints, recalls, field actions, etc.)
• Maintain a complaint reporting system consistent with the global complaint handling process; coordinate activities pertaining to proactively address emerging and potential customer issues
• Support to ensure appropriate response to problem solving for quality issues; ensure involvement of relevant regional and global stakeholders
• Prepare and present quality and customer satisfaction data for regular management reviews; lead the annual Management review with the regional leadership team

Ensure the implementation and maintenance of Integrated Management Systems which support the needs of the business and ensure compliance with regulations:

• Establish and maintain an Integrated Management System (IMS) including required certifications and relevant processes within the US Sales and Service subsidiary in accordance with global requirements and guidelines
• Manage an internal audit program within the US Sales and Service subsidiary; ensure sufficient internal audit resources for US and region NA
• Manage external audits by regulatory bodies and customers for the US Sales and Service
• Perform/support internal and external audits for relevant standards (e.g. ISO 9001, ISO 13485, ISO 14001, ISO 45001) in other Draeger subsidiaries as directed by the global Quality organization
• Maintain a corrective and preventive action (CAPA) program within the US Sales and Service subsidiary consistent with Draeger global processes to address nonconformities from internal or external audits as well as other sources

Monitor and improve handling of tasks for regulatory market access:

• Drive actions to achieve all required local product approvals and registrations in close collaboration with local and global regulatory managers for Safety Detection products

• Drive improvements in US and the NA region by collaboration and provision of relevant quality and regulatory knowledge

Ensure implementation, maintenance and development of an effective Environmental, Health and Safety system (EH&S) driven by the Director, EH&S NA.

Provides the interface between the US Sales and Service Subsidiary, other Draeger organizations, customers, and regulatory bodies for matters associated with:

• Product Recalls
• Field Actions
• Product Advisory Notices
• Incident investigations or reporting
• External audits by regulatory bodies and customers
• Product approvals

• Education: BA/BS in Business, Engineering, or Quality related degree; MBA desired
• 8-10 years in Quality System development, implementation and management in a medical and safety device company.
• 5+ years handling Regulatory related activities
• 5+ years in Quality/Regulatory management position
• Demonstrated ability to develop, implement, and manage an integrated Quality Management System
• Effective informal and formal, verbal and presentation communication skills
• Sound conflict management skills to facilitate discussions internally and with external customers and regulatory bodies (e.g. TUV or FDA)
• Strong influencing skills to lead executive management, peers, and subordinates
• Certified Quality/Regulatory auditor
• Strong knowledge of FDA QSR requirements
• Strong knowledge of NIOSH and MSHA requirements