Job Overview
We are seeking a dynamic and detail-oriented Quality Manager specializing in ISO 13485 and AS9100 standards within a high-precision machine shop environment. This pivotal role drives the development, implementation, and continuous improvement of quality management systems to ensure compliance with industry regulations and customer expectations. As a leader in quality assurance, you will champion a culture of excellence, fostering collaboration across departments to uphold the highest standards of manufacturing quality, safety, and regulatory adherence. Your expertise will help propel our operations toward operational excellence and customer satisfaction.
Responsibilities
- Lead the development, maintenance, and enhancement of quality management systems aligned with ISO 13485 (medical device quality) and AS9100 (aerospace quality) standards.
- Oversee internal and external quality audits to verify compliance with ISO 9001, FDA regulations, HACCP, CGMP, and other relevant standards.
- Coordinate and conduct thorough quality inspections and control processes throughout manufacturing operations to identify root causes of issues and implement corrective actions promptly.
- Develop, implement, and monitor quality assurance policies, procedures, and documentation to ensure consistent product quality and regulatory compliance.
- Facilitate training programs for staff on quality systems, regulatory requirements, and best practices in manufacturing, QA/QC processes.
- Collaborate with cross-functional teams on project management initiatives aimed at process improvements, risk mitigation, and product reliability enhancements.
- Analyze data from quality audits, inspection reports, and process metrics to identify trends and opportunities for continuous improvement.
Requirements
- Proven experience managing ISO 13485 and AS9100 quality systems within a manufacturing or machine shop environment.
- Strong knowledge of FDA regulations, HACCP principles, CGMP practices, ISO 9001 standards, and industry-specific compliance requirements.
- Demonstrated expertise in conducting comprehensive quality audits and inspections across production lines.
- Exceptional analysis skills to interpret complex data sets for root cause analysis and process optimization.
- Excellent project management capabilities with a track record of leading cross-departmental initiatives.
- Effective communication skills to train staff and collaborate with stakeholders at all levels.
- Bachelor’s degree in Engineering, Quality Management or related field; certifications such as CQE (Certified Quality Engineer) are preferred. Join us as we uphold rigorous standards of excellence in manufacturing! Your leadership will be instrumental in ensuring our products meet the highest levels of safety, reliability, and regulatory compliance—driving innovation while maintaining unwavering commitment to quality.
Pay: $125,000.00 - $150,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Vision insurance
Work Location: In person
