Job ID 20000F3D
Available Openings 1
PURPOSE AND SCOPE:
Updates logs, databases and catalogues of product, manufacturing and regulatory compliance information. Coordinates the review and revision of procedures, specifications and forms. Prepares process and status reports, assigns and monitors document numbers and reviews documents for accuracy and completeness. Assists in compiling regulatory filing documents and maintaining computerized files to support all documentation systems.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- As a skilled specialist, completes documentation tasks in resourceful and effective ways which include, but are not limited to creating and maintaining documentation and drawings and managing documents.
- Edit documents in accordance with formatting and template requirements.
- Master documents to meet priority timelines and coordinate compliance driven dependencies.
- Manage electronic and paper master documents; perform routine library and archiving functions.
- Support manufacturing, R&D and other functional groups.
- Must be capable of following controlled procedures
- Direct / educate others to ensure proper documentation procedures are used.
- Acts as a subject matter expert in assigned scope of controlled document lifecycle and/or records management processes.
- Determines methods and procedures on new assignments.
- May act as an informal team leader and provides assistance to junior staff with support tasks that require considerable judgment and initiative.
- May escalate difficult/complex issues to supervisor for resolution, as deemed necessary.
- Assist with various projects as assigned by direct supervisor.
- Other duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
- The physical demands and 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.
- Bending, carrying, kneeling, lifting, vision, hearing, sitting, maneuvering, pushing, and pulling, reaching, standing, stooping and walking.
- Able to lift 50 lbs. with assistance.
- High School Diploma required; Associate's Degree desirable; and Bachelor's Degree strongly preferred
EXPERIENCE AND REQUIRED SKILLS:
- 4 – 6 years' related experience.
- Ability to follow Quality Assurance procedures
- Self-motivated / self-starter, ability to carefully review documentation.
- Ability to be very organized with files and other documentation.
- Must be detail-oriented and thorough.
- Superior organizational skills.
- Basic understanding of Geometric Dimensioning & Toleranceing (GD&T).
- Must have extensive computer related experience, Autocad, Solidworks and Microsoft Word.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.
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