Berufsbezeichnung: Document Control Manager 100%

Arbeitsbeschreibung:
Strive for excellence is in our DNA. Since 1993, we have been helping the world’s leading companies imagine, design, engineer, and deliver software that changes the world. We are more than just specialists are. We are experts.

DESCRIPTION:
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.


REQUIREMENTS
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. Additional qualifications are as follows:

- 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.

RESPONSIBILITES:
- 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.

WE OFFER:
- Experience exchange with colleagues all around the world;
- Competitive compensation depending on experience and skills;
- Regular assessments and salary reviews;
- 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.

Wie Sie sich bewerben:
jobs_ch (at) epam.com

Angestelltenname: EPAM Systems (Switzerland) GmbH