Noah Medical

Schedule post market surveillance reviews and complete post market surveillance reports based on EU MDR requirements and MDCG best practices.. Coordinate with clinical, marketing, sales, regulatory, and R&D to obtain their respective post market surveillance information based on the EU MDR requirements. Working knowledge of EU MDR post-market surveillance requirements.. Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options. Learning & Development Opportunities: On-demand online training and book reimbursement

complaints

About The Team: 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. A Day In The Life Of Our Manager, Complaints and Post-Market : Perform a wide variety of activities to ensure compliance with applicable quality and regulatory requirements. Oversee day-to-day activities of the complaint handling team, ensuring complaints are handled promptly and accurately Review complaint files to ensure all complaint elements have been addressed and properly documented within the complaint file Manage vigilance reporting activities including decision rationale and reporting documentation. Submit vigilance reports to regulatory authorities Manage complaint metrics and analytics including trending and measure against statistical trend limits Schedule post market surveillance reviews and complete post market surveillance reports based on EU MDR requirements and MDCG best practices. Coordinate with clinical, marketing, sales, regulatory, and R&D to obtain their respective post market surveillance information based on the EU MDR requirements Initiate risk file updates based on post market data such as complaint rates and new hazards Review customer inquiries and service reports for potential complaints Identify and escalate complaints for potential adverse events and vigilance reporting decisions Assist in audits (internal and external). May also conduct internal audits as needed. Other QMS activities as assigned About You: 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. Workplace Type: Onsite Benefits & Perks (For Full Time Employees): Competitive Salary Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options Equity & Bonus Program Life Insurance (company paid & supplemental) and Disability insurance Mental health support through medical insurance programs Legal and Pet Insurance 12+ paid holidays, 15-20 days of PTO + use-what-you-need sick days Paid parental leave In-office snacks and beverages In-office lunch stipend Learning & Development Opportunities: On-demand online training and book reimbursement Team building and company organized social and celebration events #LI-Onsite #J-18808-Ljbffr

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