About the Company:

CAIRE is a global engineering solutions and medical device company providing leading oxygen related products to the Healthcare and Industrial/Commercial markets. We support customers in over 100 countries and have operating facilities in the US, Germany, UK, Italy, Japan and China.

In 2018 CAIRE joined NGK/NTK, a global industrial spark plug company with a growing healthcare and environmental portfolio of products. CAIRE is a wholly owned subsidiary of NGK/NTK but operates predominately as an independent company with headquarters just north of Atlanta in Ball Ground, Ga. Read more CAIRE news at www.caireinc.com.

About the position:

The Director of Global Quality owns the development and execution of a holistic quality assurance program in support of CAIRE’s global operations. The Director leads a team of quality professionals that drive key processes to include Quality Plan Creation, Training, Product Quality Review & Assurance, Compliance Analysis, Validation protocols, CAPA Management, Non Conformance Review & Approval and Supplier Evaluation, Selection and Management. This position will report directly to the VP of Global Operations.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Lead and manage the quality team, providing guidance across the organization in the implementation of plans and procedures that drive achievements of quality goals.
• Manage team performance; addressing disciplinary issues, hiring, assisting people with career development, communicating information to direct reports and passing information up the management chain, administrative processing, and maintaining trust and confidentiality; and ensuring the team is aligned with and accomplishing goals/objectives.
• Develop departmental strategy and vision to ensure adherence with customer expectations, enforce consistent and continual improvements, and monitor global quality metrics.
• Directs collection and analysis of quality information from multiple sources to develop long-term quality strategy and programs.
• Leads production process analyses, ensuring quality standards are met and making recommendations for quality improvements.
• Develops and implements program quality plans and procedures.
• Embed and sustain a culture of awareness, inquisitiveness, and persistence around process and product quality improvements.
• Foster a safety-first mentality while improving efficiencies through the improvement of process flow, elimination of waste, and cost reduction through leadership, example, and training.
• Ability to influence and build strong and trusted working relationships with internal and external business stakeholders at all levels
• Establishes and ensures supplier quality standards are acceptable and sustainable through the deployment of inspection processes; both at incoming and throughout the manufacturing processes where appropriate.
• Interface with supply chain to improve and confirm purchase part quality and reliability.
• Ensure critical suppliers are held to the highest standards and are monitored appropriately through audit programs.
• Facilitate cooperation with operations, engineering, and sales to improve purchase part quality and reliability.
• Communicate effectively with internal and external customers.
• Prepare periodic reports identifying root cause(s) for product returns, identify corrective action(s), and make recommendations to improve overall longevity of product.
• Provide leadership and the application of problem-solving initiatives through systemic tools such as lean manufacturing and six sigma.

This is a hands-on position for an individual who understands medical product demands, manufacturing workflow and quality processes

Other duties and responsibilities as assigned.

Competencies

• Excellent personal skills in leadership, coaching and both written and verbal communication.
• Proven success in leading diverse groups of engineers, managers, and technicians.
• In depth understanding and experience with Quality Systems, including ISO, MDD, and FDA requirements.
• General knowledge of pressure vessel codes.
• Experienced understanding of business software use, CAD systems, and Quality & Design Control systems.
• Thorough knowledge of quality standards, engineering design principles, and process flow evaluation and improvements.

Supervisory Responsibility

This position manages all employees of the quality departments and is responsible for the performance management and hiring of the employees within that department.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Frequent standing, sitting, walking, bending, stooping, twisting and occasional crawling.
• Occasional lifting, up to 50 lbs., occasional heavier lifting.
• Occasional pushing, pulling and handling of materials.

Travel

This position requires up to 30% travel. Some of the travel is international.

Required Education and Experience

• Education – BSME or other technical degree. MS, MBA, or MOT degree preferred but not required.
• Minimum of 10 years engineering and or quality experience, preferably in medical device related field.
• Minimum 5 years previous management experience in a technical field.
• Broad knowledge of quality applications and manufacturing processes.
• Demonstrated knowledge of engineering systems.

Preferred Education and Experience

MBA or master’s degree.

Additional Eligibility Qualifications

None required for this position.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.