The Quality Systems Team Lead is a supervisor in the Quality Systems department responsible for the effectiveness and efficiency of the Management Controls processes. They manage day-to-day operations and provide leadership and direction to the functional team.
Responsibilities- - Coordinate third party audit activities, including activities to assess and update the quality system in response to those audits.- Monitor progress on various projects and tasks to provide project resource estimates, team resource allocation, where appropriate approval, and ensure overall objectives and time lines are met.- Provide technical and non-technical direction for projects/tasks.- Serve as subject matter expert for Management Control Key Process, including coaching and mentoring team members concerning the processes and general quality system compliance to applicable requirements and external standards.- Collaborate with other departments to achieve desired results in audit responses, quality system change tracking, and regulatory compliance analyses.- Attend, present and provide data for meetings to include project updates and reviews.- Participate in hiring, interviewing and on-boarding process of new hires.- Provide input for annual performance reviews.- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.- Identify and communicate training and developmental needs for team members to management and vice versa.- Must work and interact effectively and professionally with and for others throughout various levels of the global organization.- Must strictly adhere to safety requirements.- Maintain regular and punctual attendance.- Must maintain company quality and quantity standards.- Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with minimal supervision.- Ability to remain calm and receptive in fast paced situations.
Qualifications
Bachelor's degree in Engineering, Policy Analysis, Physical Sciences, or related area or 10 years Quality Engineering/Quality Assurance
Minimum 3 years of experience working in a Medical Device or Life Sciences Quality Management System.Experience in quality audits, managing projects, and analyzing regulations- Working knowledge of 21 CFR 820, ISO 13485
Proficient in Microsoft Word/Excel/Outlook.Experience in performing gap analyses; preferred
Works under general office environmental conditions.Sitting for extended periods, utilizes close visual acuity for working with computers, etc.Occasionally required to lift up to 50 lbs. from floor to waist to move tables, chairs for appropriate room set up.
Occasionally required to stand; walk and stoop, kneel or crouch, communicate.Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA.
Top Skills
What We Do
At Cook, we are building our future on Invention, Connection, People, and Community.
As a privately owned company, we can look at the world our own way and do what we feel passionate about. What are we passionate about? That’s simple: Making unique, quality products and connecting with people to improve lives on both sides of the device.
Central to our focus on building deep connections is our belief in the importance of identifying innovative solutions to help customers, patients, employees, and communities thrive. We understand that our ongoing success will come from creating inclusive, supportive, and healthy environments where we can prosper together. Our people are our greatest asset and are at the heart of everything we do. Come build with us.
