Manager, Complaints and Post-Market

About the role

Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple indications. We are looking for exceptional engineers and key team members. Our incredibly talented team of engineers, innovators, and industry leaders bring years of experience from the top healthcare companies in the world, including: Intuitive, Auris, Stryker, Johnson & Johnson, Boston Scientific, Verb Surgical, Mako, Think Surgical, Medrobotics, and Hansen. We are looking for talented, motivated and ambitious team members to revolutionize robotic surgery. 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 Work closely with Product Quality Engineering team to ensure that investigations and complaints are completed and closed out in a timely manner Review complaint files to ensure all complaint elements have been addressed and properly documented within the complaint file Manage adverse event reporting activities including decision rationale and reporting documentation. Submit adverse event 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 applicable regulatory requirements Coordinate with clinical, marketing, sales, regulatory, and R&D to obtain their respective post market surveillance information based on regulatory requirements Support 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 event reporting decisions Perform complaint case final reviews for closure Manage complaint handling team activities and provide guidance as needed Review, revise and create SOPs (Standard Operating Procedures) and/or WIs (Work Instructions) related to complaint handling, adverse event reporting Own CAPA and/or Nonconformances pertaining to complaints and adverse event reporting. Prepare SOPs and WIs and gather data as needed to support ISO 13485:2016 clause 8.2.1 Feedback and for OUS regulatory requirements 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. 5 years' experience with a degree or 9 years without a degree 3+ 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. Strong Working knowledge of US FDA 21 CFR 820, 803, and 806 requirements Basic Working knowledge of OUS adverse event reporting requirements Basic Working knowledge of OUS post market surveillance requirements Working statistical knowledge as it pertains to trending Intermediate understanding of mechanical and software aspects of medical devices #LI-Hybrid Pay Transparency The Pay Range for this position is listed. Noah Medical offers a comprehensive benefits package including: competitive pay, health insurance, 401K and stock purchase plans, tuition reimbursement, paid time off plus holidays, and a flexible approach to work with remote, hybrid, field or office work schedules. Actual pay will be adjusted based on an individual's skills, experience, education, and other job-related factors such as location as permitted by law. Total compensation may also include additional forms of incentives. California Pay Range $141,000 - $177,000 USD 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

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