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QMS Supervisor - Medical Devices
Job
Actalent
Baldwin, NY (In Person)
$100,000 Salary, Full-Time
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Job Description
Quality Management Systems Supervisor Book here for more information: https://talentassistant.actalentservices.com/assistant/bookings/BfUTMTxl The Quality Management Systems (QMS) Supervisor is responsible for overseeing the development, implementation, and ongoing maintenance of the organization's Quality Management System to ensure compliance with applicable regulatory and industry standards. This role partners closely with cross‑functional teams to promote a strong culture of quality, support audit readiness, and drive continuous improvement initiatives across the organization. Reporting into Quality leadership, this individual plays a hands‑on role in audit management, CAPA oversight, document control, and QMS performance monitoring while serving as a key resource for quality training and compliance guidance. Key Responsibilities Own and maintain the Quality Management System structure, including policies, procedures, SOPs, and work instructions, ensuring alignment with regulatory requirements and organizational objectives Support and lead internal and external audits (registrar, customer, supplier, regulatory), including audit preparation, hosting, and response execution Lead root cause investigations for nonconformances, deviations, and customer complaints; develop, implement, and verify effective Corrective and Preventive Actions (CAPAs) Drive continuous improvement initiatives utilizing Lean principles, statistical tools, and data analysis to improve quality and operational efficiency Oversee electronic Quality Management Systems (eQMS) and document control processes to ensure accuracy, version control, and compliance Develop, trend, and present quality metrics and KPIs to leadership to support data‑driven decision‑making Deliver QMS, GMP, and compliance training to cross‑functional personnel to reinforce quality awareness and accountability Ensure alignment and consistency of Quality programs across the organization Regularly review and improve quality processes to enhance effectiveness, manage risk, and control costs Skills Capa, Quality assurance, Medical device, root cause analysis, regulatory affairs, audits, ISO 13485, AS9100, iso 9001 Top Skills Details Capa,Quality assurance,Medical device,root cause analysis,regulatory affairs,audits Additional Skills & Qualifications Required Skills & Experience Minimum of 5 years of experience in a Quality Management Systems or Quality Assurance leadership role within a regulated industry Strong working knowledge of ISO standards (ISO 13485 and/or
ISO 9001
) and audit processes Proven experience leading CAPA investigations, root cause analysis, and effectiveness checks Hands‑on experience administering and maintaining an electronic QMS platform Expertise in document control systems, change management, and training record management Ability to analyze quality data, identify trends, and implement sustainable corrective actions Excellent written and verbal communication skills, including the ability to interface with auditors, customers, and internal stakeholders Demonstrated ability to influence cross‑functional teams and lead through collaboration without direct authority Strong organizational skills with high attention to detail in regulated documentation environments Preferred Qualifications Experience in the medical device Knowledge of FDA Quality System Regulation (QSR) and GMP requirements Certified Internal Auditor (ISO 13485/9001), ASQ Certified Quality Auditor (CQA), or Certified Quality Engineer (CQE) Lean Six Sigma Green Belt or Black Belt Experience supporting manufacturing, R D, and operations teams within a compliance‑driven environment Experience Level Expert Level Job Type & Location This is a Permanent position based out of Baldwin, NY. Pay and Benefits The pay range for this position is $95000.00 - $105000.00/yr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - They match 25% of 1%, up to 4%.
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave) - 18 total days of