Quality Manager

Quality Manager Eypex Corporation Pontiac, MI Job Details Full-time 1 day ago Qualifications Food production Operational analysis Teamwork ISO standards

FDA 21 CFR

Part 11 GMP Manufacturing facility Analysis skills Medical device manufacturing facility experience HACCP Attention to detail Regulatory/legal compliance standards in production Biomedical regulatory compliance Full Job Description Job Overview 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 champion the development, implementation, and continuous improvement of quality systems to ensure our products meet the highest standards of safety, compliance, and excellence. Your energetic leadership will drive a culture of quality, fostering collaboration across teams to uphold regulatory requirements and enhance customer satisfaction. This is an exciting opportunity for a proactive professional passionate about maintaining rigorous quality standards and advancing operational excellence. Duties Develop, implement, and maintain comprehensive quality management systems aligned with industry standards such as

ISO 13485, ISO 9001, FDA

regulations, HACCP, CGMP, and other relevant frameworks. Lead quality audits internally and with suppliers to identify areas for improvement and ensure compliance with regulatory requirements. Oversee quality control processes including inspections, testing, and validation activities to guarantee product integrity from raw materials to finished goods. Collaborate with manufacturing teams to establish robust quality assurance protocols that prevent defects and optimize production efficiency. Conduct root cause analysis on quality issues, implement corrective actions, and monitor their effectiveness to prevent recurrence. Manage documentation related to quality systems, audit reports, non-conformance reports, and compliance records with meticulous attention to detail. Drive continuous improvement initiatives by analyzing data trends and implementing innovative solutions that enhance product quality and operational performance. Experience Proven experience in a Quality Management role within a manufacturing environment, ideally in sectors such as medical devices or food production. Extensive knowledge of

ISO 13485

(medical device quality management), FDA regulations (21 CFR Part 11), HACCP principles, CGMP standards, and

ISO 9001

is essential. Demonstrated success in conducting comprehensive quality audits and implementing effective corrective actions. Strong background in quality control techniques including inspection methods and testing procedures. Excellent analysis skills with the ability to interpret complex data sets and make data-driven decisions. Project management experience is highly desirable for leading cross-functional improvement projects. Exceptional communication skills to effectively train teams on quality standards and foster a culture of continuous improvement. Join us in shaping the future of high-quality products through unwavering commitment to excellence!

Work Location:

In person