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Team Lead, Quality Systems
Company : Cook Medical
Location : Vandergrift, PA, 15690
Job Type : Full Time
Date Posted : 3 January 2026
Overview
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.
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Frequently asked questions
A Team Lead in Quality Systems plays a pivotal role in steering project schedules and allocating team resources efficiently. Their oversight ensures audits, compliance tasks, and corrective actions meet deadlines, optimizing productivity while maintaining high-quality standards within medical device manufacturing.
Leadership in quality systems demands expertise in regulatory standards like 21 CFR 820 and ISO 13485, along with strong audit management and process improvement skills. This contrasts with general engineering leads by emphasizing compliance and quality assurance within life sciences environments.
Professionals often advance to senior quality management roles or regulatory affairs leadership after gaining experience as a Quality Systems Team Lead. Their ability to bridge technical compliance and operational leadership makes them strong candidates for director-level positions in healthcare and medical device sectors.
In Vandergrift, PA, certifications like ASQ Certified Quality Engineer (CQE) and Certified Manager of Quality/Organizational Excellence (CMQ/OE) are highly regarded. These credentials enhance candidates’ credibility and align well with local medical manufacturing industry standards.
Cook Medical’s Vandergrift site actively seeks experienced quality systems leaders due to ongoing expansion in medical device production. Candidates with audit expertise and regulatory knowledge find competitive opportunities, reflecting a robust local demand for quality assurance professionals.
Cook Medical fosters a collaborative environment emphasizing continuous improvement and compliance excellence. This culture influences Team Leads to engage cross-functionally, promote mentorship, and uphold rigorous quality standards while adapting to evolving regulatory landscapes.
Salaries for Team Leads in Quality Systems around Vandergrift typically range from $85,000 to $105,000 annually, depending on experience and certifications. This reflects the specialized nature of medical device quality management roles within the regional job market.
Vandergrift’s work environments often require Team Leads to balance desk-based audit planning with occasional physical tasks like equipment setup. Candidates should be prepared for some lifting and mobility, consistent with manufacturing settings common in this Pennsylvania locale.
Key challenges include navigating stringent regulatory audits, aligning cross-departmental quality initiatives, and maintaining team morale under tight deadlines. Effective communication and adaptability are crucial for managing these dynamics successfully at Cook Medical.
The hiring approach at Cook Medical emphasizes thorough evaluation of candidates’ audit experience and regulatory expertise. Onboarding includes tailored training on company-specific quality protocols, fostering early engagement and alignment with organizational compliance goals.