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The Quality Systems Specialist II position is responsible for the support of a compliant and effective quality management system. Primary quality system functions include Corrective Action and Preventive Action (CAPA), Nonconformance Management, Internal and External Audit, Document and Records Management, Change Control, Training, and Quality Metric Analysis and Review.
Job Responsibility
Develops and maintains quality system procedures to ensure compliance with regulations and industry standards
Participates in internal and external quality audits to ensure compliance with regulations and standards
Participates in, or leads, the completion of CAPA projects, assuring compliance, quality, and timeliness of records
Investigate and resolve quality issues, including conducting root cause analysis and implementing corrective and preventive actions
Leads meetings and communications for CAPA updates, information, and concerns
Monitors and analyzes quality metrics to identify areas for improvement and initiate corrective actions
Provides backup support for engineering change orders and other document change requests
Develops and maintains electronic quality management system processes
Provides cross-functional training and support as needed
Collaborates with cross-functional teams to ensure quality standards are met throughout the product lifecycle
Communicates quality system updates and changes to relevant stakeholders
Provides guidance and training to the organization on quality system requirements and best practices
Performs other duties as assigned
Requirements
Bachelor’s degree in a related technical field
3-5 years of experience in quality assurance or other quality systems roles in the medical device industry
Previous CAPA and nonconformance experience and demonstrated use of quality tools and methodologies
Detailed knowledge of 21 CFR Part 820, ISO 13485, EU MDR, and other global regulatory requirements
Advanced computer skills, including statistical/data analysis and report writing skills
Strong verbal and written communication skills
Excellent attention to detail
Multitasks prioritize and meet deadlines promptly
What we offer
Medical
Dental
Vision
Health Savings Accounts
Health Care & Dependent Care Flexible Spending Accounts