Quality Manager Company Overview Our client is a world-class manufacturer and recognized leader in the plastics industry. For more than two decades, the company has built a strong reputation for delivering exceptional product quality, outstanding service, and innovative solutions to its customers. Their continued success is driven by a strong commitment to their employees, customers, and continuous improvement. This is an excellent opportunity to join a growing organization that values quality, teamwork, professional development, and operational excellence. Position Overview The Quality Manager will be responsible for leading and maintaining the organization's Quality Management System and managing the quality team. This individual will play a key role in ensuring compliance with applicable quality standards and regulatory requirements while driving continuous improvement throughout the manufacturing operation. The ideal candidate will be a hands-on quality leader with strong experience in quality systems, auditing, root cause analysis, process improvement, and team development. Key Responsibilities Lead, maintain, and continuously improve the company's Quality Management System. Ensure compliance with

ISO 9001, ISO 13485, FDA

requirements, and other applicable quality and regulatory standards. Plan, coordinate, and support internal audits and external audit activities. Maintain and control quality documentation, including procedures, control plans, work instructions, and quality records. Lead and oversee quality training programs for manufacturing and quality personnel. Investigate quality issues and lead root cause analysis and corrective and preventive action activities. Develop, implement, and monitor Corrective Action Requests (CARs) to ensure timely and effective resolution of quality issues. Manage and track departmental Key Performance Indicators (KPIs) and develop action plans to improve performance. Lead quality improvement and continuous improvement initiatives throughout the manufacturing operation. Partner with production, engineering, and other cross-functional teams to improve processes, reduce defects, and enhance overall product quality. Apply Lean Manufacturing and continuous improvement methodologies to improve operational and quality performance. Lead, mentor, and develop members of the quality team. Qualifications Bachelor's degree in Engineering, Quality, Manufacturing, Business Management, or a related field preferred; equivalent combination of education and relevant quality experience will be considered. Minimum of five years of relevant quality assurance or quality control experience. Minimum of three years of experience in a Quality Management or Quality Leadership role. Experience supporting ISO 9001 and

ISO 13485

Quality Management Systems. Internal or Lead Auditor certification for ISO 9001 and/or

ISO 13485

preferred, or equivalent auditing training and experience. FDA compliance experience preferred. Strong experience with root cause analysis, corrective actions, process controls, and continuous improvement. Knowledge of Statistical Process Control (SPC), Kaizen, Lean Manufacturing, Six Sigma, and other quality improvement methodologies. ASQ, CQM/OE, CQE, or other relevant quality certifications are preferred. Strong leadership, communication, organizational, and problem-solving skills. H1

Job Type:

Full-time Pay:

$150,000.00 - $180,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Paid time off

Education:

Bachelor's (Preferred)

Experience:

ISO 13485

5 years (Preferred)

Work Location:

In person