Overview We are seeking a highly skilled and detail-oriented Quality Manager to lead our quality assurance and control initiatives within our manufacturing operations. This pivotal role involves overseeing the development, implementation, and continuous improvement of quality systems to ensure compliance with industry standards, regulatory requirements, and customer expectations. The ideal candidate will possess extensive experience in quality management within industrial or manufacturing environments, demonstrating strong leadership, analytical skills, and a commitment to excellence. Key responsibilities include establishing rigorous quality standards, conducting comprehensive audits, and fostering a culture of continuous improvement. The Quality Manager will collaborate across departments to ensure adherence to regulatory and legal compliance standards such as FDA regulations, ISO 9001, ISO 13485, GMP (Good Manufacturing Practice), and HACCP (Hazard Analysis Critical Control Point). This role offers an opportunity to influence product quality at every stage of production while maintaining operational efficiency. Duties Develop, implement, and maintain comprehensive quality management systems aligned with industry standards such as

ISO 9001, ISO

13485, GMP, and Lean management principles. Lead and coordinate internal and external quality audits to verify compliance with regulatory requirements including FDA regulations. Oversee quality control processes including inspection procedures, GD&T (Geometric Dimensioning & Tolerancing), and QA/QC protocols to ensure products meet specified quality standards. Conduct root cause analysis for non-conformities using Six Sigma methodologies; implement corrective and preventive actions. Manage the documentation of quality procedures, audit reports, and compliance records accurately for regulatory inspections. Facilitate cross-functional communication between manufacturing, engineering, procurement, and regulatory teams to uphold quality standards. Lead continuous improvement initiatives aimed at reducing waste, enhancing efficiency, and optimizing manufacturing processes through Lean management techniques. Train staff on quality assurance practices including

GMP, HACCP, CGMP

(Current Good Manufacturing Practice), and other regulatory standards. Monitor key performance indicators related to product quality; analyze data trends to identify areas for improvement. Ensure that all manufacturing activities comply with legal requirements and industry regulations such as FDA regulations for medical devices or pharmaceuticals. Skills Extensive knowledge of quality standards in production including

ISO 9001, ISO 13485, GMP, HACCP, CGMP.

Proven experience in conducting quality audits and implementing corrective actions. Strong understanding of regulatory/legal compliance standards relevant to manufacturing industries. Expertise in applying Six Sigma tools for process improvement and defect reduction. Proficiency in GD&T principles for precise measurement and inspection of components. Familiarity with quality systems such as QA/QC frameworks and Lean management strategies. Excellent leadership skills with the ability to manage cross-functional teams effectively. Strong analytical skills for data analysis and root cause investigation. Effective project management capabilities to oversee multiple initiatives simultaneously. Exceptional communication skills for training staff and collaborating across departments. This position offers an engaging opportunity for professionals committed to maintaining the highest levels of product integrity while fostering innovation within a dynamic manufacturing environment. If you possess a passion for quality assurance coupled with technical expertise in industrial or manufacturing engineering roles, we invite you to apply today.

Pay:

$90,000.00 - $115,000.00 per year

Work Location:

In person