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 products meet the highest standards of safety, compliance, and excellence. Your leadership will drive a culture of quality, foster cross-functional collaboration, and uphold regulatory and legal standards to support our commitment to delivering superior products to our customers. This is an exciting opportunity for a proactive professional passionate about elevating quality management practices in an industrial or manufacturing setting.
Responsibilities
- Develop, implement, and maintain comprehensive quality management systems aligned with ISO 9001 standards and other relevant regulatory frameworks such as FDA regulations and GMP guidelines.
- Lead regular quality audits across production processes to identify areas for improvement, ensuring adherence to HACCP, CGMP, Lean management, and Six Sigma methodologies.
- Oversee quality inspection procedures, ensuring rigorous testing and validation of raw materials, in-process components, and finished products against established quality standards.
- Ensure compliance with all regulatory and legal requirements by staying current with industry standards such as ISO, GAMP, GD&T (Geometric Dimensioning & Tolerancing), and other applicable regulations.
- Manage a team of quality professionals by providing training, guidance, and performance feedback to foster a high-performance culture focused on continuous improvement.
- Collaborate with cross-functional teams including manufacturing, engineering, supply chain, and regulatory affairs to integrate quality assurance into all stages of production.
- Analyze data from quality audits, inspection reports, and process controls to identify trends, root causes of defects or non-conformities, and implement corrective actions promptly.
Skills
- Proven experience practicing in an industrial or manufacturing engineering role with a strong understanding of manufacturing processes and quality control principles.
- Expertise in ISO 9001 standards along with knowledge of ISO requirements; familiarity with ISO 13485 or other industry-specific standards is a plus.
- Strong knowledge of HACCP principles, CGMP regulations, FDA compliance standards, GMP practices, and regulatory/legal compliance in production environments.
- Skilled in conducting thorough quality audits utilizing tools such as Six Sigma DMAIC methodology; proficiency in GxP (Good Practice) guidelines is desirable.
- Excellent analysis skills with the ability to interpret complex data sets for process improvements; experience with QA/QC software systems preferred.
- Effective team leadership capabilities combined with cross-functional communication skills to drive organizational alignment on quality initiatives.
- Project management expertise to oversee multiple initiatives simultaneously while maintaining focus on strategic goals related to lean management and continuous improvement.
Join us as we strive for excellence in every product we deliver! Your expertise will help shape our future by ensuring the highest levels of quality assurance while fostering innovation within our manufacturing environment.
Benefits:
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Work Location: In person
