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Senior Manager of Quality (Complaints & Post Market Surveillance)

Senior Manager of Quality (Complaints & Post Market Surveillance)

HealthCare Recruiters InternationalSanta Clara, CA, United States
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Senior Manager of Quality (Complaints & Post Market Surveillance)

Client

Our client has recently developed a commercialized next-generation robotic platform that targets early diagnosis and treatment of patients across multiple disease states.

This Sr. Manager of Complaints & Post Market will be integral to ensuring products, services, and processes are of the highest quality and meet customer and regulatory requirements.

A Day In The Life Of Our Manager of Complaints and Post-Market Surveillance

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.

    • 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.
  • 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
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    Senior Manager Quality • Santa Clara, CA, United States

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