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Document Control Manager

  • Boston, MA, USA
  • hot
Job #: 45409
Ranked as #12 on Forbes’ List of 25 Fastest Growing Public Tech Companies for 2017, EPAM is committed to providing our global team of 30,100+ 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



EPAM Continuum is looking for an exceptional Document Control Manager to join its multidisciplinary team of engineers, designers, and strategists to work in our EPAM Boston office. EPAM Continuum projects span the consumer, medical, and industrial segments and include a broad range of mechanical engineering content.

The Documentation Control Manager leads and manages all aspects our EPAM Boston 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.

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What You’ll Do

  • The Documentation Control Manager is responsible for the overall management and maintenance of the documentation control system for EPAM Boston. 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
  • 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
  • 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
  • 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

What You Have

  • 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
  • A 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

What We Offer

  • Experience exchange with colleagues all around the world
  • Competitive compensation depending on experience and skills
  • Regular assessments and salary review
  • Develop integration modules for interacting with new systems and applications
  • Opportunities for self-realization
  • Friendly team and enjoyable working environment
  • Corporate and social events
  • Unlimited access to LinkedIn learning solutions

Equal Employment Opportunity

EPAM Systems, Inc. is an equal opportunity employer.  We recognize the value of diversity and inclusion in creating success for our customers, business partners, shareholders, employees and communities. We are committed to recruiting, hiring, developing and promoting employees without discrimination. As a global employer, this commitment includes complying with all laws in the countries in which we operate. Nevertheless, we believe equal employment practices should not be limited to what the law requires. Equal opportunity and inclusion are essential to motivate, empower and recognize the best in everyone.

At EPAM, employment actions are based on individual qualifications, without regard to race, color, religion, creed, gender, pregnancy status, sexual orientation, gender identity, gender expression, marital or familial status, national origin, ancestry, genetics, age, disability status, veteran status, citizenship status when otherwise legally able to work, or any other characteristic protected by law.

Pay Transparency Non-Discrimination Provision

EPAM will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

Affirmative Action Obligations as a U.S. Government Federal Contractor

As a U.S. federal government contractor, EPAM is committed to meet its affirmative action obligations to make good faith efforts to expand the recruiting pool of women, minorities, individuals with disabilities, and protected veterans through outreach, targeted recruitment, training opportunities and other activities. We affirm this commitment annually in EPAM’s Affirmative Action Plans. The full text of our Affirmative Action Plan for Persons with a Disability and Protected Veterans is available for inspection in the People Operations Department during normal business hours. Email the People Operations Department to schedule an appointment.

Accessibility for Applicants with Disabilities

EPAM is committed to working with and providing reasonable accommodation to individuals with disabilities. If you require an accommodation at any stage of the employment application process, please send an email to the People Operations Department including your name, a detailed description of your requested accommodation, and the best method to contact you. If you have already reviewed a job posting or submitted an application for a job, please include the requisition number. We will assist you and make a determination on your accommodation request on a case-by-case basis.

EEO is the Law. Applicants to and employees of EPAM Systems Inc., are protected under Federal law from discrimination.

EPAM Systems, Inc. participates in eVerify.

Background investigations are required for all new hires as a condition of employment, after the job offer is made. Employment will not begin until EPAM Systems receives and approves the results of the background check.

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