Director, Quality Assurance

The Director, Quality Assurance is responsible for providing leadership to the Quality Assurance Team through the setting of goals, developing resources, and fostering a professional environment that collaborates work with oterhs throughout the Cook organization to develop innovative and forward thinking strategies with respect to quality. This position oversees the responsibilities performed by the Quality Assurance Team.

• Ensure the Cook Research Management System (CRMS) is understood, implemented, and remains effective throughout CRI;
• Fulfill the responsibilities of Management Representative;
• Promote cross-functional interactions within CRI to achieve quality outputs and to improve the CRMS;
• Provide vision, direction, development, and leadership to the Quality Assurance Team in support of the CRI Management System;
• Engage with Quality leadership through the Cook organization to ensure the site continues to be responsive to changing quality expectations;
• Develop strategies that integrate and support the goals and direction of Cook Medical;
• Be knowledgeable of and stay current on regulations and standards as they apply to work performed by CRI;
• Work with HR to recruit, interview, select, hire, and orient new employees;
• Plan and allocate resources to effectively staff and accomplish work to meet functional and company expectations for productivity and quality goals;
• Foster an environment where the giving and receiving of feedback is encouraged;
• Facilitate the annual employee performance review process coordinated by HR;
• Encourage employee contributions through goal setting, feedback, and performance development planning;
• Consult HR to document, administer and resolve employee disciplinary action if required;
• Maintain ongoing communication with employees through team meetings, one-on-one meetings, email, and other appropriate forms of communication;
• Review and approve employee requests through appropriate pathways and according to company policies (e.g., expense reports, purchase orders, PTO approval, education and tuition assistance, and hardware/software workflows);
• Establish trusted relationships with Cook colleagues, management, and external stakeholders by providing respectful, mindful and purposeful communication and maintaining a commitment to exceeding expectations; and
• Understand, practice and model the principles of honesty and integrity as outlined in the Cook Global Code of Conduct

• Bachelor’s degree in a scientific or engineering discipline, Masters or PhD preferred;
• 10+ years QA experience working in the medical device, biotechnology, or pharmaceutical industry;
• 5+ years in leadership role;
• Conscientious, influential person with an outstanding work ethic and strong personal discipline;
• Sufficiently assertive to deal with confrontational situations;
• Excellent organizational and problem-solving skills;
• Excellent written, listening and verbal communication skills;
• Ability and desire to work in a collegial team atmosphere; including communicating and working constructively with colleagues; and

• Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.