Sr. QA Manager

IRIDEX Corporation is a medical device manufacturer and operates in a global regulated environment (e.g. FDA). Regulations include (but are not limited to) FDA 21 CFR 820, EN ISO 13485, and the European Medical Regulation (MDR). Based on the position, experience in a regulated environment and the extent of working knowledge of appropriate regulations may vary. PURPOSE OF JOB: The Quality Assurance department is devoted to assuring safe, reliable and effective products that exceed patient, physician and hospital/clinic expectations. The department plays a vital role in product and process quality supporting commercial production for all Iridex products including laser consoles, delivery devices and accessories. The Sr. Quality Assurance (QA) Manager is responsible for managing and implementing the required actions to maintain existing product lines and to solve any product quality issues while working with internal departments/business units to appropriately remedy them. Responsibilities include strategic quality system insight and direction, quality systems management, management of the Quality Systems group, and budget management. Additionally, this role will help facilitate internal training on quality assurance requirements, processes, and procedures. MAJOR DUTIES AND RESPONSIBILITIES: Oversee a dedicated Quality Assurance team, providing guidance, and direction across operational and functional areas to ensure product and process quality. Proactively identifies areas for process improvements and collaborate with management to develop effective solutions aligned with business objectives. Manage and plan internal audits collaboratively with the Director of Regulatory Affairs. Manage supplier quality assurance activities including but not limited to supporting new supplier approval, monitoring performance of existing suppliers, and performing supplier quality audits Perform analytical, statistical and trending analyses on complaint data to support timely management review and proactive response or corrective action Review/write product investigation reports. Provide analyses and trending data, including initiating formal investigations and/or corrective action requests resulting from product complaints. Ensures that the Quality Management System is established, implemented, and maintained in accordance with established regulations (FDA, ISO13485, & other International requirements) as imposed and reports on the performance of the quality management system to management for review and as a basis for improvement. Evaluate existing quality system procedures and processes for compliance with applicable regulatory requirements Develop formal written reports to communicate audit results to management and regulatory compliance agencies Escalate to direct management all quality issues that could impact patient safety or surgical efficacy Perform other duties as assigned by management JOB SKILLS: Ability to document the analyses of product complaints for trends and identification of potential corrective or preventive actions Recommend improvements in quality system to ensure that the quality system is efficient and effective controls are in place to minimize risk. Good documentation skills and attention to detail. Complete projects in a timely manner and consistent with corporate objectives. QUALIFICATIONS: Bachelor’s Degree Minimum 5-7 years of Quality Assurance experience with at least 2 years in the medical device industry 2+ years of experience managing people/teams Advanced problem-solving skills including troubleshooting and root cause analysis Must be able to communicate complex technical issues clearly in English both verbally and in writing Demonstrated understanding of medical device QMS requirements and regulatory requirements, including but not limited to ISO 13485:2016, 21CFR820 and MDSAP Familiarity with risk management tools Knowledge of quality system auditing; [auditing certifications (e.g. lead auditor, quality auditor, biomedical auditor) are a plus] ADDITIONAL INFORMATION: Department:

Quality Assurance Reports To: CEO FLSA Status: Exempt Annual Base Salary : $165,000 - $175,000 (DoE) Work Location : 100% onsite in Mountain View, CA

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