Chief Executive Officer
Manager of Complaints and Post MarketSan Carlos, CA
The Quality team is an integral part of ensuring products, services, and processes are of the highest quality and meet customer and regulatory requirements. We are a team of detail-oriented professionals who take pride in meticulously assessing processes, products, and services to identify and rectify issues, ensuring the utmost quality and customer satisfaction. If you share our passion for maintaining the highest standards of quality and are dedicated to making a positive impact, we invite you to consider joining our Quality Assurance Team. Together, we can continue to elevate our organization’s quality standards and provide unparalleled value to our customers and stakeholders.
Product Decontamination and Complaint Investigations:
• Conduct hands-on product decontamination and complaint investigations.
• Work in a lab environment, handling potentially biohazardous materials.
• Strictly adhere to lab safety protocols and enforce them within the complaint investigation lab.Documentation and Reporting:
• Write comprehensive complaint investigation reports.
• Review complaint files to ensure all elements are properly addressed and documented.
• Perform routine complaint trending and measure against statistical trend limits and action limits.Post Market Surveillance:
• Schedule and complete post-market surveillance reviews, aligning with EU MDR requirements and MDCG best practices.
• Coordinate with cross-functional teams (clinical, marketing, sales, regulatory, and R&D) to gather post-market surveillance information.
• Initiate risk file updates based on post-market data, such as complaint rates and new hazards.Event Reporting:
• Review customer inquiries and service reports for potential complaints.
• Identify and escalate potential adverse events for vigilance reporting decisions.
• Complete vigilance reporting decisions and provide rationale.
• Submit vigilance reports to regulatory authorities.Audits and Process Improvement:
• Assist in both internal and external audits and may conduct internal audits as required.
• Contribute to the development and updating of complaint and post-market surveillance procedures and templates.
• Undertake other Quality Management System (QMS) activities as assigned.
- At minimum a BS degree in a technical field such as engineering, computer science, or a science-related discipline.
- 10+ years of complaint-handling experience in the medical device industry.
- Ability to manage others, their work, and your own multiple competing priorities.
- Working knowledge of the entire complaint handling process from intake, investigation, closure, and reportability assessments.
- Working knowledge of EU MDR post-market surveillance requirements.
- Working statistical knowledge as it pertains to trending
- Intermediate understanding of mechanical and software aspects of medical devices.
- Basic understanding of the medical device design, manufacturing, and field service processes
- Preferred certified Quality Engineer (ASQ CQE) and/or certified Quality Manager / Organizational Excellence ASQ CMQ/OE
- Excellent presentation speaking and technical report writing skills
Working at Noah
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