Quality Manager

Job Summary We are seeking a dynamic and detail-oriented Quality Manager to lead our quality assurance and control initiatives across manufacturing operations. In this pivotal role, you will develop, implement, and maintain comprehensive quality systems that ensure our products meet the highest standards of safety, efficacy, and compliance. Your leadership will drive continuous improvement, foster a culture of quality excellence, and ensure adherence to regulatory requirements such as

ISO 13485, FDA

regulations, HACCP, CGMP, and

ISO 9001.

If you thrive in a fast-paced environment and are passionate about delivering top-tier quality, this is your opportunity to make a significant impact! Duties Develop and oversee the implementation of robust quality management systems aligned with industry standards and regulatory requirements. Conduct regular quality audits to assess compliance with

ISO 13485, FDA

regulations, HACCP, CGMP, ISO 9001, and other relevant standards. Lead root cause analysis and corrective action processes to resolve quality issues efficiently and prevent recurrence. Manage quality inspections and control processes throughout manufacturing to ensure product integrity and safety. Collaborate with cross-functional teams on new product development projects to embed quality assurance from inception through production. Train staff on quality procedures, standards, and best practices to foster a culture of continuous improvement. Prepare detailed reports on quality metrics, audit findings, and compliance status for executive review. Skills Extensive knowledge of

ISO 13485

(medical device quality management), FDA regulations (21 CFR Part 820), HACCP principles for food safety, CGMP standards for pharmaceuticals or biotech products, and

ISO 9001.

Proven experience conducting comprehensive quality audits within manufacturing environments. Strong expertise in quality control techniques, inspection methods, and quality assurance processes. Ability to analyze complex data sets to identify trends and areas for improvement using advanced analysis skills. Project management skills to coordinate multiple initiatives simultaneously while maintaining attention to detail. Excellent communication skills for training teams, preparing reports, and collaborating with regulatory bodies. Demonstrated leadership in developing and maintaining effective quality systems that support operational excellence. Join us as a Quality Manager to lead our commitment to excellence! Bring your expertise in quality management systems, regulatory compliance, and process improvement to help us deliver safe, reliable products while fostering a culture of continuous enhancement. Your dedication will ensure our products meet the highest standards of safety and performance—making a real difference in the lives of our customers!

Work Location:

In person