Quality Manager

*Job Overview* The information below covers the role requirements, expected candidate experience, and accompanying qualifications. We are seeking an experienced and detail-oriented *Quality Manager* to lead and oversee our quality assurance and control processes within our manufacturing operations. The ideal candidate will ensure compliance with industry standards, regulatory requirements, and internal quality systems. This role is critical in maintaining the highest standards of product quality, safety, and efficiency, supporting continuous improvement initiatives across the organization. *Duties* * Develop, implement, and maintain comprehensive quality management systems aligned with ISO 13485, ISO 9001, FDA regulations, HACCP, CGMP, and other relevant standards. * Conduct regular *quality audits* to evaluate compliance with internal policies and external regulations. * Lead *quality inspections* throughout the manufacturing process to identify defects or deviations from specifications. * Oversee *quality control* procedures and ensure proper documentation of quality metrics and non-conformances. * Collaborate with cross-functional teams on *project management* initiatives to improve product quality and manufacturing efficiency. * Analyze data to identify trends and root causes of quality issues, implementing corrective and preventive actions. * Train staff on quality systems, standards, and best practices to foster a culture of continuous improvement. * Ensure compliance with regulatory agencies' requirements and prepare documentation for audits or inspections. * Drive initiatives for process improvements based on *analysis skills* and industry best practices. *Requirements* * Proven experience in *quality management* within a manufacturing environment, preferably in regulated industries such as medical devices or pharmaceuticals. * Strong knowledge of *ISO 13485*, *FDA regulations*, *HACCP*, *CGMP*, and *ISO 9001* standards. * Demonstrated expertise in conducting *quality audits*, inspections, and implementing *QA/QC* procedures. * Solid understanding of *quality systems*, *quality assurance*, *quality control*, and *quality inspection* methodologies. * Excellent project management skills with the ability to lead cross-functional teams effectively. * Strong analytical skills for data analysis, root cause analysis, and problem-solving. * Effective communication skills to train staff and collaborate with various departments. * Relevant certifications in quality management or auditing are a plus. This position offers an opportunity to play a pivotal role in maintaining the integrity of our products while fostering a culture of excellence through rigorous quality standards. Job Type: Full-time Pay: $64,999.39 - $78,278.83 per year Benefits: * 401(k) * 401(k) matching * Dental insurance * Employee assistance program * Employee discount * Flexible schedule * Flexible spending account * Health insurance * Health savings account * Life insurance * Paid time off * Parental leave * Professional development assistance * Referral program * Retirement plan * Tuition reimbursement * Vision insurance Work Location: In person