Overview We are seeking a dynamic and detail-oriented Quality Operations Manager to lead our quality assurance and control initiatives within our manufacturing environment. This pivotal role involves overseeing the implementation and maintenance of quality systems, ensuring compliance with industry standards and regulatory requirements, and driving continuous improvement across production processes. The ideal candidate will possess a passion for excellence, strong leadership skills, and a comprehensive understanding of quality management principles to ensure our products meet the highest standards of safety, efficacy, and customer satisfaction. Duties Develop, implement, and maintain robust quality management systems aligned with

ISO 9001, ISO 13485

(medical devices), GMP, and other relevant standards. Lead quality audits—both internal and external—to verify compliance with

HACCP, CGMP, FDA

regulations, and legal requirements. Oversee quality inspection processes throughout production to identify defects, analyze root causes, and implement corrective actions promptly. Collaborate with cross-functional teams—including manufacturing, engineering, and regulatory affairs—to ensure adherence to quality standards in all phases of production. Conduct risk assessments using Six Sigma methodologies and apply Lean management principles to optimize manufacturing efficiency while maintaining quality integrity. Manage regulatory compliance activities related to FDA regulations, ISO standards, and other applicable legal frameworks. Lead training initiatives to promote a culture of quality awareness among staff and ensure consistent application of quality procedures. Utilize analysis skills to interpret data from quality metrics, audits, and inspections to identify trends and areas for process improvement. Qualifications Proven experience practicing in an industrial or manufacturing engineering role with a focus on quality assurance or control. Strong knowledge of

HACCP, CGMP, GMP, ISO 9001, ISO 13485

standards, and FDA regulations. Demonstrated expertise in conducting quality audits and implementing quality systems across manufacturing environments. Familiarity with GDT (Geometric Dimensioning & Tolerancing), GD&T principles for precise engineering measurements. Skilled in Six Sigma manufacturing techniques and lean management strategies for process optimization. Excellent project management skills with the ability to lead cross-functional teams effectively. Exceptional analysis skills to interpret complex data sets for continuous improvement initiatives. Strong communication skills to facilitate collaboration across departments and ensure regulatory compliance. Join us in shaping the future of high-quality manufacturing! We are committed to fostering an environment where innovation thrives through rigorous quality practices—empowering you to make a meaningful impact every day.

Pay:

From $35.00 per hour Expected hours: 25.0 - 40.0 per week

Benefits:

Health insurance Paid time off

Work Location:

Hybrid remote in Princeton, NJ 08540