A Quality Manager manages quality control in an organization or for a project. Develops quality control policies and monitors quality in different settings such as manufacturing production, technology product development and research laboratories
ISO Specialist AdvanceCRE Portland, OR Job Details Full-time $40 - $60 an hour 11 hours ago Qualifications ISO certification process Teamwork Compliance audits & assessments Analysis skills Attention to detail Regulatory/legal compliance standards in production Biomedical regulatory compliance Quality audits Manufacturing Hazard analysis Legal compliance FDA regulations Full Job Description Job Summary We are seeking a highly motivated and detail-oriented ISO Specialist to lead our organization's quality management initiatives and ensure compliance with international standards. In this pivotal role, you will develop, implement, and maintain robust quality systems aligned with ISO 9001 and
ISO 13485
standards, fostering a culture of continuous improvement. Your expertise will drive adherence to regulatory and legal requirements, support manufacturing excellence, and enhance overall product quality. Join us to make a significant impact on our quality assurance processes and help uphold our commitment to excellence in manufacturing. Responsibilities Develop, implement, and maintain comprehensive ISO quality management systems in accordance with
ISO 9001, ISO
13485, and other relevant standards. Conduct regular internal and external quality audits to verify compliance with industry standards, regulatory requirements, and company policies. Lead root cause analysis and corrective action initiatives to resolve quality issues efficiently and prevent recurrence. Collaborate with cross-functional teams—including manufacturing, engineering, regulatory affairs, and supply chain—to ensure quality standards are integrated into all processes. Facilitate training sessions on HACCP (Hazard Analysis Critical Control Point), CGMP (Current Good Manufacturing Practices), GMP (Good Manufacturing Practices), Lean management, Six Sigma methodologies, and other quality systems. Monitor adherence to FDA regulations, legal compliance standards, and industry-specific requirements such as GAMP (Good Automated Manufacturing Practice) where applicable. Support continuous improvement projects utilizing analysis skills and project management techniques to optimize manufacturing efficiency and product quality. Qualifications Proven experience practicing in an industrial or manufacturing engineering role with a focus on quality assurance or control. Strong knowledge of
ISO 9001, ISO 13485
(medical devices), HACCP, CGMP, GMP, FDA regulations, and regulatory compliance standards. Demonstrated expertise in conducting quality audits and implementing quality standards in production environments. Familiarity with Six Sigma manufacturing principles, Lean management practices, GD&T (Geometric Dimensioning & Tolerancing), and QA/QC processes. Excellent analysis skills for root cause investigation, data interpretation, and process optimization. Effective team leadership abilities coupled with strong cross-functional communication skills to foster collaboration across departments. Project management experience to oversee initiatives that enhance quality systems and operational excellence. Join us as an ISO Specialist to champion our commitment to delivering high-quality products while ensuring compliance with global standards!
