Team Lead, Quality Systems

Overview

The Team Lead, Quality Systems, leads and develops the CRI Quality System team by providing technical expertise in QMS processes — including CAPA, document control, and metrics monitoring — while ensuring regulatory compliance and alignment with Cook's global business objectives. This role balances hands-on quality system oversight with people leadership responsibilities such as hiring, coaching, and performance management, fostering a culture of accountability and continuous improvement.

Responsibilities

Distribute work assignments and establish priorities to ensure customer’s expectations are met;

Encourage and foster employee development through mentorship and training;

Provide leadership in accordance with company policies, procedures, applicable laws and regulations that apply to your business activities;  

Develop and maintain a working knowledge of the Quality System and the quality responsibilities and tasks; 

Provide technical expertise to team members with respect to quality system processes (e.g., CAPA, document and record control, external and internal document management, metrics and monitoring)

Ensure QMS activities (e.g., CAPA, change requests, metrics and monitoring) are executed, documented, and completed;

Work cross-functionally within Quality Assurance Team providing leadership and guidance as needed;

Ensure the Quality System is implemented and compliant;

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.

Qualifications

A minimum of a Bachelor’s degree in a technical discipline;

Relevant experience working in a medical device, biotech, or pharmaceutical company;

Willingness and capability to handle multiple projects and responsibilities;

Excellent organizational, leadership, and problem-solving skills;

Excellent computer, written, and verbal communication skills;

Ability and desire to work in a collegial team atmosphere; including communicating and working constructively with colleagues;

Sufficiently assertive to deal with confrontational situations;

This role requires fluency in Artificial Intelligence (AI) and data concepts, including the ability to critically evaluate AI outputs, improve workflows using approved tools, identify and mitigate bias or inaccuracies, and communicate AI-driven insights clearly and responsibly to peers and managers; 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.