Cutera, Inc. is seeking a Quality Assurance Engineer to support its Quality team. The role focuses on ensuring QMS compliance with applicable regulations and standards, managing CAPA and customer complaint processes, supporting supplier quality activities, and leading validation activities for quality system software.
Support compliance of the QMS with 21 CFR Part 820, ISO 13485:2016, EU MDR, MDSAP, and other applicable regulatory requirements
Support the development, maintenance, and improvement of Standard Operating Procedures (SOPs), forms, templates, and other quality system documentation
Manage customer complaint investigations from intake through closure
Support investigation activities including root cause analysis, correction, containment and identification of corrective actions
Monitor complaint trends and recurring failure modes to identify opportunities for CAPA and product/process improvements
Support the administration and maintenance of the electronic CAPA system
Participate in CAPA Review Board activities and support the effective execution of the CAPA process
Review CAPA investigations and corrective/preventive action plans for completeness, accuracy, and timely execution
Monitor corrective and preventive actions and follow up with cross-functional teams to support timely completion and effectiveness
Support supplier quality activities including supplier qualification, performance monitoring, SCARs, incoming quality issues and ongoing supplier improvement
Assist with supplier changes and quality related change notifications
Support supplier audits and assessments, including preparation, follow-up and tracking of corrective actions to closure
Support validation activities for new and existing QMS software in compliance with 21 CFR Part 11
Assist in defining software validation requirements, specifications, and acceptance criteria for non-product software systems
Develop and execute validation deliverables, including test plans, test cases, and validation reports
Support internal and external audits and inspections, including FDA and notified body audits
Participate in internal quality audits and assist with the identification and resolution of audit findings
Track and report quality metrics, including nonconformances, CAPAs, audit findings, and complaints
Prepare quality reports, presentations, and other materials to support quality initiatives and management review
Collaborate with cross-functional teams to identify opportunities for process improvement and maintain QMS effectiveness
Other duties as needed or required
Qualification
Required
Bachelor's degree in Science, Engineering, or a related field
1-3 years of experience in a highly regulated medical device or similarly regulated environment
Working knowledge of applicable regulations and standards, including 21 CFR Part 820, ISO 13485:2016, and 21 CFR Part 11
Familiarity with CAPA and customer complaint processes, quality systems, and internal audits
Ability to work effectively on cross-functional projects and collaborate with teams across the organization
Strong analytical, organizational, planning, and problem-solving skills
Proficiency in Microsoft Office and familiarity with PLM and ERP systems
Ability to manage multiple priorities and work effectively in a fast-paced, deadline-driven, team-oriented environment
High attention to detail, organization, and accuracy
Strong verbal, written, and interpersonal communication skills
Preferred
Experience or working knowledge of software validation or computerized system validation is preferred
Experience in a medical device manufacturing environment
Familiarity with MDSAP, EU MDR, and FDA Quality System requirements
Experience with electronic QMS (eQMS) or quality management software
Experience supporting CAPA, Customer complaints, nonconformance, audit, or document control processes
Experience with validation of non-product software or computerized systems
Benefits
Cutera, Inc. is a leading global aesthetics device company with a comprehensive product portfolio and a global distribution footprint.
