Endologix, Inc

  • Document Control Supervisor

    Job ID
    2018-1911
    Location
    US-CA-Santa Rosa
    Category
    Quality
  • Overview

    Endologix develops and manufactures minimally invasive treatments for aortic disorders. We offer a dynamic, growth environment, competitive compensation and benefits, and a challenging, fulfilling experience in a fast-paced, growing company. Medical device professionals have the opportunity to develop and further their careers in a dynamic company that features the latest innovations in endovascular aneurysm repair and sealing.

     

    Job Scope:

    The Document Control Supervisor is responsible for the hiring, training, scheduling and performance management of a site Document Control (DC) team. The Supervisor oversees quality record archival and training tracking, and manages and implements the processes associated with the creation of new, and revision of existing, documents throughout the complete product lifecycle in a regulated medical device company.

    Responsibilities

    • Serves as primary communication hub for site functional teams regarding documentation, training, records and change control information; provides support and guidance to groups and subject matter experts for activities related to the development and maintenance of site documentation, procedures, guidelines, and templates.
    • Responsible for regulatory compliance, document accuracy per GMP and internal policies and procedures, timely completion, and version control of new and revised documentation.
    • Performs continuous coordination, monitoring and expediting of document changes to meet established deadlines for regulatory submission and production, as well as product launches.
    • Develops and delivers training regarding change control processes and supporting systems-based tools to promote high quality documentation, efficient processes, and compliance with quality system requirements.
    • Performs operations in the systems which partner with the document control system (e.g., MES, ERP), confirming accuracy of uploads and appropriate notification to user groups. Owns and ensures that appropriate follow-up actions are taken to completion.
    • Leads and participates in departmental process improvement projects.
    • Participates in and responds to internal and external audits; ensures timely response to auditor and user requests for documentation.
    • Investigates and responds to corrective actions related to document and records controls, training, and external standards.
    • Responsible for accurate and timely distribution and retrieval of controlled copies, ensuring users have the current revision and are prevented from unintended use of superseded documents.
    • Monitors documentation system function; investigates and coordinates with System Administrator on any issues.
    • Maintains site DC staff by recruiting, selecting, orienting, and training employees; develops personal growth opportunities; mentors and motivates staff for success.
    • Supervises site DC personnel and schedules, and assigns and prioritizes their activities.
    • Provides support and guidance in DC team and individual goal-setting, performs quarterly progress reviews, and prepares and delivers annual performance reviews. Sets clear performance standards and holds team accountable for results; values, recognizes and rewards the achievement of others; promotes teamwork.
    • Controls expenses and provides input on resource needs; suggests process improvements to properly manage needs within budget constraints.
    • Prepares and provides applicable metrics data to site management quarterly.
    • Provides quality service by enforcing quality and customer service standards.
    • Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications.
    • Perform other duties as assigned by manager.
    • Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
    • Strong verbal, written, organizational and time management skills.
    • Strong team building, partnering and interpersonal skills.
    • Strong computer skills, including working knowledge of MS Office and e-mail.
    • Strong problem solving and customer service skills.
    • Thorough understanding of change control and documentation regulations (medical/safety/regulatory/corporate).

    Qualifications

    Minimum Education & Licensing:

    • Bachelor’s degree from an accredited higher learning institution or higher in scientific field or equivalent in number of years of experience

    Minimum Experience:

    • 7+ years combined experience in the pharmaceutical, biologics or medical device industries.
    • Thorough understanding of change control and documentation regulations (medical/safety/regulatory/corporate).
    • Extensive experience with electronic document control system.
    • Strong problem solving skills.
    • Experience in cGMP/GDP/GCP environments and FDA regulated industries strongly preferred.

    Specific Skills, Knowledge & Behaviors

    Supervisor Core Competencies:

    Leading Change: Develops and implements strategies and approaches for leading and managing organizational transformation at individual , functional, and enterprise levels, and influences change where needed

    Inspiring the Workforce: A compelling storyteller, motivates and engages employees at individual and group levels towards results

    Selecting & Developing Talent: Assesses, selects, coaches, mentors, provides constructive feedback, empowers and develops the workforce at individual and group levels

    Strategic thinking: Creates the vision and direction, assesses priorities, understands , analyzes, and acts upon drivers of business and operational success at a departmental, functional, and/or enterprise level

    Global & systems thinking: Understands and embraces global nuances, leads across functions and geographies, builds alignment across diverse groups , and looks at the company holistically

    External Industry Leadership & Knowledge: Connects with and influences health care and/or functional industry regulatory and government organizations, and understands external industry factors that impact the company and products

    Continuous Improvement: Leverages best practices tools and methodologies to assess, identify, and executes on opportunities to improve; Focus on learning and building new capabilities into self and team

    Problem Solving & Problem Prevention: Uses strong problem solving methodologies and tools, focuses on root cause analysis, and shows orientation towards problem prevention

    Accountability: Drives and focuses on results, takes initiative without direction, takes broad ownership for all work within scope, builds relationships and works across departments, functions, or areas of responsibility

    Interpersonal Effectiveness: Actively seeks to understand perspectives and interpersonal needs and expectations of others at all levels, builds self-awareness, flexes personal style appropriately, and works through conflicts constructively and appropriately

    Communication: Effectively uses all mediums of communication as appropriate, presents well to groups, actively listens, and continuously identifies opportunities to build communication skills

    Collaboration & Teamwork: Actively works together with formal and informal team members to build relationships and achieve team goals

    Prioritization: Effectively prioritizes work to ensure timely completion of work within scope

    Global & Systems Thinking: Continuously seeks to learn about and embrace global nuances, works across functions and geographies, seeks to align with diverse groups, and seeks to understand interdependencies and impacts of actions across functions and the company

    Technical Expertise: Continuously builds functional and technical expertise, and pro-actively applies that technical expertise in progressively broader scope

    Continuous Improvement: Learns and uses best practices tools and methodologies to assess, identify, and executes on opportunities to improve; Focus on learning and building new capabilities into self

    Problem Solving & Problem Prevention: Learns and uses strong problem solving methodologies and tools, focuses on root cause analysis, and shows orientation towards problem prevention

    Accountability: Focuses on results, takes initiative without direction, takes ownership for all work within scope, builds relationships and works across departments, functions, or areas of responsibility

     

     

    Endologix, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity, gender expression, genetic information, marital status, veteran status or any other characteristic protected by applicable federal, state, or local law.

                                                

    If you are a qualified individual with a disability or a disabled veteran, you have the right to request an accommodation if you are unable or limited in your ability to use or access our career center as a result of your disability. To request an accommodation, contact a Human Resources Representative at Endologix Global Headquarters at 949-595-7200 or Endologix Santa Rosa Facility at 707-543-8800

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