Quality Management Systems Supervisor HumanHire is partnering with a growing manufacturer in the regulated healthcare industry to hire a Quality Management Systems Supervisor. This is an excellent opportunity for an experienced quality professional to take ownership of an established Quality Management System while driving compliance, regulatory compliance, and continuous improvement. This role is ideal for someone who enjoys working cross-functionally, leading quality initiatives, and ensuring products and processes consistently meet industry standards.

Compensation & Benefits Salary:

Up to $110,000 annually, based on experience Comprehensive medical, dental, and vision insurance 401(k) with company match Paid time off and company holidays Opportunities for professional growth and advancement Responsibilities Oversee and maintain the organization's Quality Management System (QMS), ensuring compliance with applicable industry regulations and quality standards. Develop, update, and manage quality policies, standard operating procedures (SOPs), work instructions, and document control processes. Coordinate and lead internal quality audits while supporting customer, registrar, and regulatory audits. Manage Corrective and Preventive Action (CAPA) activities, including root cause investigations, corrective actions, and effectiveness verification. Analyze quality data, trends, and key performance indicators (KPIs) to identify opportunities for process improvement. Lead continuous improvement initiatives utilizing Lean principles, Statistical Process Control (SPC), and other quality methodologies. Maintain and administer the electronic Quality Management System (eQMS) to ensure documentation remains accurate, current, and audit-ready. Collaborate with engineering, manufacturing, operations, and leadership teams to strengthen quality processes across the organization. Develop and deliver employee training related to quality systems, regulatory compliance, and Good Manufacturing Practices (GMP). Review existing procedures and workflows to improve efficiency, maintain compliance, and support organizational quality goals. Qualifications Bachelor's degree in Engineering, Biomedical Engineering, Life Sciences, Quality Management, or a related technical field. At least 5 years of Quality Management Systems or Quality Assurance experience within a regulated manufacturing environment. Strong knowledge of

ISO 9001, ISO

13485, AS9100, or similar quality management standards. Experience leading internal audits and supporting customer or regulatory audits. Hands-on experience with CAPA, Root Cause Analysis (RCA), Failure Mode and Effects Analysis (FMEA), Statistical Process Control (SPC), and continuous improvement initiatives. Experience administering or maintaining electronic Quality Management Systems (eQMS). Excellent analytical, communication, and organizational skills. Ability to work independently while collaborating effectively with cross-functional teams. Preferred Qualifications Experience within the medical device, pharmaceutical, life sciences, aerospace, or another highly regulated manufacturing environment. Certified Internal Auditor certification. ASQ Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE). Lean Six Sigma Green Belt or Black Belt certification. Experience managing document control systems and regulatory compliance programs. to be considered. A recruiter will follow up within 48 hours. HumanHire is a national executive search and staffing firm with a leadership team that has over 50 years of experience as trusted industry professionals specializing in direct hire, temp to hire, temporary and payrolling services. We have multiple highly specialized divisions. Within the Healthcare industry, we specialize in the following and more - Healthcare Administration & Management Medical Billing & Coding Behavioral & Mental Health Nursing Allied Health Professionals Health Information Technology (HIT) Rehabilitation Services Laboratory & Diagnostic Services Emergency & Critical Care Public Health & Community Health Revenue Cycle Management Patient Access & Registration Medical Office Administration Hospital & Clinic Operations Compliance & Risk Management Managed Care & Insurance Operations Medical Receptionist, Medical Front Desk, Patient Coordinator, or Healthcare Customer Service Representative.

Pay:

Up to $110,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Life insurance Paid time off Vision insurance

Work Location:

In person