Manager, Complaints and Post-Market
About The Position
Noah Medical is building the future of medical robotics with a next-generation robotic platform targeting early diagnosis and treatment across multiple indications. The Quality team is integral to ensuring products, services, and processes meet the highest quality and regulatory requirements. This role will oversee the day-to-day activities of the complaint handling team, ensuring prompt and accurate complaint management, and collaborating with the Product Quality Engineering team for timely investigation and closure of complaints. The position involves managing adverse event reporting, including decision rationale and documentation, and submitting reports to regulatory authorities. Key responsibilities include managing complaint metrics and analytics, scheduling and completing post-market surveillance reviews, and coordinating with various departments to gather post-market surveillance information. The role also supports risk file updates based on post-market data, reviews customer inquiries for potential complaints, and identifies complaints for adverse event reporting decisions. The Manager will perform final reviews of complaint cases for closure, manage and guide the complaint handling team, and revise/create SOPs and WIs related to complaint handling and adverse event reporting. This position owns CAPA and/or Nonconformances pertaining to complaints and adverse event reporting, prepares documentation for ISO 13485:2016 and OUS regulatory requirements, and assists in internal and external audits. Other QMS activities as assigned are also part of the role.
Requirements
- 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.
Responsibilities
- 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.
Benefits
- competitive pay
- health insurance
- 401K
- stock purchase plans
- tuition reimbursement
- paid time off
- holidays
- flexible approach to work with remote, hybrid, field or office work schedules
- 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, Flexible Time Off + Sick Time
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Manager
