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 that ensure our products meet the highest standards of safety, efficacy, and compliance. Your leadership will drive a culture of excellence, fostering collaboration among cross-functional teams to uphold regulatory requirements and industry best practices. 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, implement, and maintain comprehensive quality management systems aligned with IATF, ISO 9001 (quality management), FDA regulations, HACCP (hazard analysis critical control point), CGMP (current good manufacturing practices), and other relevant standards.
- Lead quality audits internally and externally to ensure compliance with regulatory requirements and identify areas for improvement.
- Oversee quality control processes including inspections, testing, and validation activities throughout the manufacturing cycle.
- Coordinate with production teams to address non-conformances promptly and implement corrective and preventive actions (CAPA).
- Conduct thorough analysis of quality data to identify trends, root causes, and opportunities for process enhancements.
- Manage documentation related to quality systems, audit reports, inspection records, and compliance certifications.
- Facilitate training programs on quality standards, procedures, and regulatory updates for staff at all levels.
Qualifications
- Proven experience in manufacturing environments with strong knowledge of IATF, ISO 9001, FDA regulations, HACCP, CGMP, QA/QC processes, and quality systems management.
- Demonstrated expertise in conducting quality audits and inspections with attention to detail.
- Exceptional analysis skills to interpret data and implement effective solutions.
- Strong project management abilities to lead cross-functional initiatives successfully.
- Excellent communication skills for training teams and collaborating with regulatory bodies.
- Bachelor’s degree in Engineering, Quality Management, or a related field; advanced certifications in quality assurance or management are preferred.
- Familiarity with industry-specific standards such as ISO 13485 for medical devices or other relevant certifications is highly desirable. Join us as a Quality Manager and be at the forefront of ensuring our products meet rigorous standards! Your expertise will help shape our commitment to excellence while advancing your career in a vibrant and supportive environment dedicated to innovation and continuous improvement.
Pay: $60,000.00 - $80,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible schedule
- Health insurance
- Paid time off
Work Location: In person