Director Quality Management (sales And Service)

Director Quality Management (Sales & Service)

Reference #: 1265923101

Business Unit: Draeger, Inc., Job-ID: 1023

Location: Telford

Function: Quality

Work Location: Hybrid

Employment Type: Permanent

The Job

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

Your Qualifications

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. UV 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

Drager Benefits

At Draeger, Technology for Life means supporting our people in every aspect of their lives. We offer a competitive benefits package that may include: Medical, dental, and vision insurance Life, short- and long-term disability coverage 401(k) with company match Over 4 weeks of paid time off, plus holidays and parental leave Flexible spending accounts and employee assistance program Select locations also offer free parking, an on-site gym, cafeteria, and game room. Talk to your Draeger recruiter to learn more!

Who We Are

We're hiring! If you want your contributions to make a real difference, check out this new career opportunity with us at Draeger where we are led by the guiding principle "Technology for Life". Draeger has several sites located across North America as well as field-based sales and service positions. Our North America headquarters is located in Telford, PA just north of Philadelphia. We also have US sites in Andover, MA, and Houston, TX. Our Canada site is located in Mississauga, Ontario. Draeger is an Equal Opportunity Employer. Interested? Please, apply directly through our career portal. We look forward to receiving your application. Draeger is an equal opportunity employer, and does not discriminate against otherwise qualified applicants on the basis of race, color, creed, religion, sexual orientation, gender identity, ancestry, national origin, age, disability, veteran status, marital status, or any other characteristic protected by law.