Quality Control Manager

Overview We are seeking a dynamic and detail-oriented Quality Control Manager to lead our quality assurance initiatives across manufacturing operations. In this pivotal role, you will oversee the development, implementation, and continuous improvement of quality systems to ensure products meet the highest standards of safety, efficacy, and compliance. Your leadership will drive a culture of excellence, fostering collaboration among cross-functional teams to uphold regulatory requirements and industry best practices. This position offers an exciting opportunity to shape quality strategies that directly impact customer satisfaction and regulatory adherence. Responsibilities Develop, implement, and maintain comprehensive quality management systems aligned with

ISO 13485

(medical devices), ISO 9001 (quality management), FDA regulations, HACCP (hazard analysis and critical control points), and CGMP (current good manufacturing practices). Lead quality audits internally and externally to verify compliance with regulatory standards and identify areas for improvement. Oversee quality control processes, including inspections, testing, and validation activities throughout the manufacturing cycle. Coordinate with production teams to ensure adherence to quality specifications and facilitate root cause analysis for any non-conformances. Manage documentation related to quality assurance activities, audit reports, corrective actions, and compliance records. Drive continuous improvement initiatives by analyzing quality data, monitoring key performance indicators, and implementing corrective/preventive actions. Provide training on quality systems, regulatory requirements, and best practices to staff at all levels. Qualifications Proven experience in manufacturing environments with a strong understanding of quality control and quality assurance principles. In-depth knowledge of

ISO 13485, ISO 9001, FDA

regulations, HACCP, CGMP standards, and related regulatory frameworks. Demonstrated expertise in conducting quality audits and implementing quality systems across complex operations. Strong analytical skills with the ability to interpret data and identify trends for process improvements. Excellent project management skills with the ability to lead cross-functional teams effectively. Exceptional communication skills to clearly convey technical information and foster a culture of quality excellence. Bachelor's degree in engineering, quality management, or a related field; advanced certifications such as CQE (Certified Quality Engineer) are preferred. Join us in elevating our commitment to excellence! This role offers a vibrant environment where your expertise will make a tangible difference—ensuring our products meet rigorous standards while supporting innovation and growth within our organization.

Pay:

$79,000.00 - $90,000.00 per year

Benefits:

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

Work Location:

In person