Skip navigation

Document Control Manager

  • Zug, Switzerland
  • hot
Job #: 45276
Ranked as #12 on Forbes’ List of 25 Fastest Growing Public Tech Companies for 2017, EPAM is committed to providing our global team of over 25,900+ EPAMers with inspiring careers from day one. EPAMers lead with passion and honesty, and think creatively. Our people are the source of our success and we value collaboration, try to always understand our customers’ business, and strive for the highest standards of excellence. No matter where you are located, you’ll join a dedicated, diverse community that will help you discover your fullest potential.

DESCRIPTION


Currently we are looking for a Document Control Manager for our Zug office to make the team even stronger.

Detail-oriented, energetic self-starter with strong communication and organizational skills. The successful candidate will have a proven ability to multi-task and work collaboratively as well as independently in a dynamic and entrepreneurial environment. The position requires a minimum of 5 years of experience in a documentation control role, and experience in management, in a Medical Device/Health Care organization.

The Documentation Control Manager is responsible for the overall management and maintenance of the documentation control system for EPAM. This includes supervision and execution of all Documentation Control activities, and personnel engaged in those activities, including the change control process, quality records archiving, etc. The position interfaces with other departments and teams to give guidance and direction to ensure that documentation complies with EPAM’s standards and regulatory requirements.

WHO YOU ARE


The Documentation Control Manager leads and manages all aspects our EPAM facility’s Document & Record Management systems in compliance with EPAM Quality system, namely QSR/ISO 13485 and FDA’s Quality System Regulation (QSR). This person will also have contact with our other offices worldwide.

Responsibilities

  • Provide management oversight and expertise in document and records management and quality records management systems
  • Manage the day-to-day engineering change control and test documentation process and provide guidance and direction to company personnel on execution
  • Manage and direct the activities of the Document Control department personnel
  • Be responsible for oversight, alignment and execution of documents with internal operations and external sources to assure compliance with our Quality System requirements
  • Develop, document and promote document control best practices
  • Own CAPAs, audit preparation and findings, and continual improvement activities as assigned by supervisor
  • Train staff on documentation and document control processes and procedures
  • Be responsible for establishing and maintaining the global standards library
  • Document Control systems (i.e.- SolidWorks PDM, EPAM Process Asset Library)
  • Assist in the development and implementation of electronic Product Lifecycle Management (PLM), and Product Data Management (PDM)
  • May own and manage the quality system hardware, software, and system process
  • Other responsibilities as assigned by supervisor

Requirements

  • Bachelor’s degree or equivalent experience in Documentation Control in a design, development and manufacturing environment. releases and versioning, naming conventions, record management, etc.)
  • Thorough understanding of document control, configuration management and engineering change control processes (e.g., part numbering, ISO 13485, etc., including Part 11 compliance)
  • Working understanding of the principles of Medical Device and healthcare regulations including FDA’s Quality System Regulation (QSR) and European regulations
  • Excellent organizational and time management skills. Detail oriented, dependable and willing to handle multiple priorities
  • Successful communication skills, business acumen and assertive decision-making ability
  • Familiar with (PDM) and Document Control systems
  • Experience with implementing (preferred), using, and managing electronic Product Lifecycle Management (PLM), Product Data Management
  • Preferred experience in software validation
  • Travel up to 25% may be needed

We offer

  • Experience exchange with colleagues all around the world
  • Competitive compensation depending on experience and skills
  • Regular assessments and salary reviews
  • Develop integration modules for interacting with new systems and applications
  • Opportunities for self-realization
  • Friendly team and enjoyable working environment
  • Corporate and social events
  • Please note that any offers will be subject to appropriate background checks
  • We do not accept CV from recruiting or staffing agencies
  • Due to the swiss labour legislation we can only accept EU candidates and applicants who have open work permit for Switzerland

Здравствуйте, чем мы можем вам помочь?


Наши офисы

  • Канада

    • Оттава

      343 Preston Street,
      ON K1S 1N4, Ottawa
      Canada

      Карта
    • Торонто

      5 Park Home Avenue,
      Suite 400,
      ON M2N 6L4, North York,
      Toronto
      Canada

      Карта
      Тел: +1-416-591-4004
      Факс: +1-416-595-1551
  • Мексика

  • США

    • Ньютаун

      41 University Drive,
      Suite 202,
      Newtown, PA 18940
      USA

      Карта
      Тел: +1-267-759-9000
      Факс: +1-267-759-8989
    • Белвью

      110 110th Ave. NE,
      Suite 310
      Bellevue, WA 98004
      USA

      Карта
    • Бостон

      21 Drydock Avenue,
      Suite 410 W,
      Boston, MA 02210
      USA

      Карта
    • Вашингтон

      7901 Jones Branch Drive,
      Suite 400,
      McLean, VA 22102
      USA

      Карта
    • Коншохокен

      101 East 8th Ave,
      Suite 201,
      Conshohocken, PA 19428
      USA

      Карта
      Тел: +1-484-382-1300
    • Лос-Анджелес

      11601 Wilshire Blvd,
      Suite 350,
      Los Angeles, CA 90025
      USA

      Карта
    • Нью-Йорк

      24 West 25th Street,
      5th Floor,
      New York, NY 10010
      USA

      Карта
      Тел: +1-267-759-9000
      Факс: +1-267-759-8989
    • Сан-Франциско

      222 Kearny Street,
      Suite 308,
      San Francisco, CA 94108
      USA

      Карта
    • Сан-Хосе

      2055 Gateway Place,
      Suite 510,
      San Jose, CA 95110
      USA

      Карта
    • Филадельфия

      30 South 15th Street,
      9th Floor,
      Philadelphia, PA 19102
      USA

      Карта
  • Австралия

  • Гонконг

  • Индия

    • Бангалор

      Smartworks,  
      Global Technology Park,
      Block C, Outer Ring Rd,
      Adarsh Palm Retreat, Bellandur,
      Bengaluru, Karnataka 560103
      India

      Карта
    • Пуна

      SmartWork Business Center Pvt Ltd,
      Suite 8, Level 1,
      West Wing, Nyati Unitree,
      Samrat Ashok Road,
      Yerwada, Pune - 411006,
      Maharashtra
      India

      Карта
    • Хайдарабад

      10, 11 & 12th Floors,
      Salarpuria Sattva Knowledge City,
      Plot No. 2, Phase - 1,
      Survey No. 83/1,
      Raidurgam Village,
      Serilingampally Mandal,
      Hyderabad, Telangana - 500081
      India

      Карта
      Тел: +91-40-47979900
  • Китай

    • Гуанчжоу

      Unit B01, 23/F,
      Yuexiuxinduhui Building,
      No. 236, 6th Zhongshan Road,
      Yuexiu District, Guangzhou,
      China 510180

      Карта
    • Сучжоу

      Building 12, Creative Industrial Park,
      328 Xinghu Street,
      Suzhou Industrial Park,
      Suzhou, China 215123

      Карта
    • Шанхай

      Room B509, 5th Floor,
      48 Weihai Road,
      Huangpu District, Shanghai,
      China 200000

      Карта
      Тел: +86-21-53080606
    • Шэньчжэнь

      3/F, Block 5, Vision Shenzhen Business Park,
      9th Gaoxin South Road, 
      Shenzhen Hi-tech Industrial Park,
      Nanshan District, Shenzhen,
      Guangdong, China 518057

      Карта
  • ОАЭ

    • Дубай

      EPAM Systems FZ-LLC
      Dubai Branch,
      Building 16, Office 241,
      Dubai Internet City,
      PO Box 501929, Dubai
      United Arab Emirates

      Карта
      Тел: +971-4-568-3569
  • Сингапур

  • Япония

    • Tokyo

      Floor 1-10-11
      Shibadaimon Centre Building 10th
      Shibadaimon Minato-ku
      Tokyo 105-0012
      Japan

      Карта
      Факс: +81-03-6880-9201