Team Lead, Quality Systems

Overview The Quality Systems Team Lead is a supervisory role within the Quality Systems department, responsible for ensuring the effectiveness and efficiency of Management Controls processes. The role involves managing daily operations and providing leadership and direction to the team. Responsibilities Coordinate third-party audit activities, including assessments and updates to the quality system based on audit findings. Monitor progress on projects and tasks, estimate resources, allocate team resources, and ensure objectives and timelines are met. Provide both technical and non-technical guidance for projects and tasks. Serve as a subject matter expert for Management Control Key Processes, coaching team members on processes and compliance with applicable standards. Collaborate with other departments to achieve audit response goals, track quality system changes, and ensure regulatory compliance. Participate in meetings, present updates, and provide data analysis. Assist in hiring, interviewing, and onboarding new team members. Contribute to annual performance reviews. Maintain all required training and seek opportunities for professional growth. Identify training needs for team members and communicate these to management. Work effectively and professionally across various organizational levels. Adhere strictly to safety protocols. Maintain regular attendance and uphold quality and quantity standards. Demonstrate effective communication skills and the ability to work independently and collaboratively. Remain calm and receptive in fast-paced situations. Qualifications Bachelor's degree in Engineering, Policy Analysis, Physical Sciences, or related field. Minimum of 3 years' experience in Medical Device or Life Sciences Quality Management Systems. Experience with quality audits, project management, and regulatory analysis. Working knowledge of 21 CFR 820 and ISO 13485. Proficiency in Microsoft Word, Excel, Outlook. Experience with gap analyses is preferred. Physical and Environmental Requirements Works in a standard office environment. Sitting for extended periods; visual acuity for computer work. Occasional lifting up to 50 lbs., standing, walking, stooping, kneeling, or crouching. Must be able to perform essential functions with reasonable accommodations under ADA.

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