Staff Quality Systems Engineer

Responsibilities

• Quality Management System (QMS): Supporting the QMS to ensure compliance with ISO 13485, FDA regulations, and other applicable regulations and standards.
• Design Control: Represent Quality to ensure design control deliverables/ activities are completed and documented per the company procedures. Design Control activities including reviewing and approving design description documents, requirement documents, risk management activities and documentation, V&V protocol and report, trace matrices, design reviews, and DHF.
• Document Control: Manage the creation, review, approval, distribution, and archiving of quality documents, including SOPs, work instructions, and quality manuals.
• Continuous Improvement: Identify opportunities for process improvements within the QMS and document control processes. Collaborate with other departments to implement system improvements to enhance efficiency and compliance.
• Training: Develop and implement training programs related to quality processes and regulatory requirements. Ensure all employees are trained and maintain training records.
• Compliance: Ensure all quality documents and processes comply with regulatory requirements and industry standards.
• Audits: Prepare for and participate in internal and external audits. Ensure all documentation is audit-ready and address any findings promptly.
• Collaboration: Work closely with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure quality requirements are met throughout the product lifecycle.
• Reporting: Generate and analyze quality metrics and reports. Present findings to management and recommend corrective actions as needed.

Experience

• Minimum of 8 years in Quality Assurance/Quality Engineering role from Medical Device or other regulated industry
• Bachelor’s degree in a related field (e.g. Quality Management, Engineering)
• In-depth knowledge of relevant Regulations and standards (e.g. FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971)
• Experience with administration of QMS and document control systems.
• Lead auditor experience preferred
• Working knowledge of design controls, risk management, software development life cycle, and statistical techniques.
• Strong written and verbal communication skills and ability to collaborate effectively
• Proficient in the use of Microsoft Office Suite