ZOLL Circulation, Inc.

  • Manager, Post Market Surveillance

    Job Locations US-CA-San Jose
    Posted Date 1 month ago(12/18/2018 11:44 AM)
    Job ID
    2018-1091
    # of Openings
    1
    Category
    Quality/Regulatory Affairs
  • Overview

    Location:  San Jose, California

     

    General Summary:

    This role leads the global business processes related to complaint handling, regulatory reporting and supports the post-market product surveillance activities.  Provide leadership and subject matter expertise to ensure that an effective system is successfully implemented and maintained.  This position is a leadership role within the organization and is accountable for identifying and championing sustainable business process improvements, improving products, and providing management with actionable business and product data.  This role requires exceptionally strong communication, interpersonal and organizational skills and a solid understanding of the application of FDA and ISO 13485 standards.

    Responsibilities

    Essential Functions:

     

    • Manages a team of Complaint Handling professionals in meeting global regulations in the areas of post-market complaint handling, global reporting, and trending.
    • Ensures timely and complaint management of complaint receipt, evaluation, investigation and closure processes.
    • Responsible for the complaint management system enhancements and process improvements. Including the Software validation process. 
    • Responsible for the identification, escalation and containment of field product quality issues.
    • Manage a team of involved functions to investigate, define root cause and propose action plans for improvement.
    • Responsible for the development and implementation of MDR and Vigilance Compliance objectives and strategic initiatives.
    • Interprets regulations for execution and recommends modification to operational procedures to ensure continued compliance.
    • Maintain current knowledge on regulatory worldwide requirement for adverse event reporting.
    • Manages a team responsible for the documentation, reportability assessment, adverse event reporting requirements, maintenance and closure of clinical study adverse events.
    • Manages the data collection and reporting of product complaints and adverse events for quality metrics.
    • Responsible for monthly and quarterly complaint management meeting with senior management.
    • Ensures team communicates complaint investigation results in a timely manner to customers and to external regulatory agencies.
    • Create a positive and collaborative work environment to ensure MDR and Vigilance regulatory expectations are achieved.
    • Represents area as a subject matter expert in support of external/ internal audits.
    • Provides training to Technical Service and Technical Support teams to ensure compliance with post market surveillance requirements.
    • Works with key partners to ensure global awareness and adherence to policy and procedures.
    • Develops, maintains and advances policy and procedures to support business and compliance needs.
    • Ensures appropriate investigations regarding reportability are initiated and documented.
    • Provides functional management for the Designated Complaint Handling team, including goals, projects, feedback, coaching, and performance reviews.
    • Performs other duties as assigned by management.

    Qualifications

    Skill Requirements:

    • Demonstrated ability to lead cross-functional teams and facilitate those teams to identify and implement solutions to complex problems.
    • Ability to manage people/resources effectively to accomplish established goals.
    • Demonstrates strong attention to detail.
    • Strong problem solving, collaboration, influencing, negotiation and conflict resolution skills.
    • Writes clearly and informatively; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.
    • Follows policies and procedures; supports organization’s goals and values.
    • Adapts to changes in the work environment; manages competing demands; changes approach or method to best fit the situation; able to deal with frequent change, delays, or unexpected events.
    • Follows instructions, responds to management direction; takes responsibility for own actions; keeps commitments; commits to long hours of work when necessary to reach goals; completes tasks on time.  Keeps and follows up on commitments.
    • Demonstrates persistence and overcomes obstacles.
    • Demonstrates accuracy and thoroughness; applies feedback to improve performance; monitors own work to ensure quality.

     

    Education/Experience Requirements:

    • BS in Science or Engineering.  Equivalent QA experience considered.
    • Experience using Microsoft Word, Excel, Visio, PowerPoint.
    • Experience: Minimum of 10 years of experience in related medical device/regulatory industry. 5 year of direct experience in medical device complaint handling and regulatory agency reporting; 5 years of supervisory/management experience.

     

    • Language Ability:

    Ability to read and interpret complex quality documents.

     

    • Math Ability:

    Ability to apply and understand basic arithmetic operations.

     

    • Reasoning Ability:

    Ability to identify potential problems and discuss findings with Quality Management.

     

    • Computer Skills:

    Working knowledge of desktop computer and software programs.

     

    • Certificates and Licenses:

    No certifications needed

     

    • Supervisory Responsibilities:

    Post Market Surveillance Coordinator, Analysts and Supervisor report to this position.

     

    • Work Environment:

    The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

     

    The noise level in the work environment is usually moderate.

     

    • Physical Demands:

    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

     

    While performing the duties of this job, the employee is regularly required to sit and talk or hear.  The employee is also required to stand; walk; use hands to finger, handle or feel and reach with hands and arms.  Specific vision abilities required by this job include close vision, distance vision and ability to adjust focus.

     

    Preferred Experience:

     

    • A demonstrated working knowledge of domestic and international regulations relative to the medical device industry is desired.
    • Strong skills in strategy, team management, and process enhancement (within the team, cross-functionally, and cross-divisionally).
    • A demonstrated working knowledge of Software Validation for Complaint Management Systems.

     

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